FdaApprovalPulse: all 386 record reports, page 2 of 2

Every FdaApprovalPulse record report, 200 per page, grouped by state. Records 201 to 386: Allurion Technologies, Inc.: PMA supplement approved for Allurion™ Gastric Balloon System to Endospan , Ltd.: PMA supplement approved for NEXUS Aortic Arch Stent Graft System. Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration).

Massachusetts

• Allurion Technologies, Inc.: PMA supplement approved for Allurion™ Gastric Balloon System
• Allurion Technologies, Inc.: PMA supplement approved for Allurion™ Gastric Balloon System
• Beaver Visitec International, Inc.: PMA supplement approved for FINEVISION HP Trifocal IOLs
• Boston Scientific Corp: PMA supplement approved for AMS 700™ Inflatable Penile Prosthesis (IPP) with and without InhibiZone™
• Boston Scientific Corporation: PMA supplement approved for Axonics Sacral Neuromodulation System
• Boston Scientific Corporation: PMA supplement approved for Axonics Sacral Neuromodulation System
• Boston Scientific Corporation: PMA supplement approved for Axonics Sacral Neuromodulation System
• Boston Scientific Corporation: PMA supplement approved for Axonics Sacral Neuromodulation System
• Boston Scientific Corporation: PMA supplement approved for TheraSphere
• Foundation Medicine, Inc.: PMA supplement approved for FoundationOne CDx
• Foundation Medicine, Inc.: PMA supplement approved for FoundationOne CDx
• Foundation Medicine, Inc.: PMA supplement approved for FoundationOne CDx
• Foundation Medicine, Inc.: PMA supplement approved for FoundationOne CDx
• Foundation Medicine, Inc.: PMA supplement approved for FoundationOne CDx (F1CDx)
• Foundation Medicine, Inc.: PMA supplement approved for FoundationOne CDx (F1CDx)
• Foundation Medicine, Inc.: PMA supplement approved for FoundationOne CDx (F1CDx)
• Foundation Medicine, Inc.: PMA supplement approved for FoundationOne Liquid CDx
• Foundation Medicine, Inc.: PMA supplement approved for FoundationOne Liquid CDx (F1 Liquid CDx)
• Foundation Medicine, Inc.: PMA supplement approved for FoundationOne® CDx
• Foundation Medicine, Inc.: PMA supplement approved for FoundationOne®Liquid CDx
• Instylla, Inc.: PMA supplement approved for Embrace(TM) Hydrogel Embolic System
• Instylla, Inc.: PMA supplement approved for Embrace(TM) Hydrogel Embolic System
• Instylla, Inc.: PMA supplement approved for Embrace® Hydrogel Embolic System
• LeMaitre Vascular, Inc.: PMA supplement approved for Artegraft Collagen Vascular Graft
• Pramand, LLC: PMA supplement approved for CraniSeal™ Dural Sealant
• Pramand, LLC: PMA supplement approved for CraniSeal Dural Sealant
• Pramand, LLC: PMA supplement approved for SpineSeal™ Spine Sealant
• Pramand, LLC: PMA supplement approved for SpineSeal Spine Sealant
• Rejoni, Inc.: PMA approval for Juveena Hydrogel System
• Siemens Healthcare Diagnostics, Inc.: PMA supplement approved for ADVIA Centaur AFP and Atellica IM Alpha Fetoprotein (AFP)
• Smith and Nephew, Inc.: PMA supplement approved for Agili-C
• TransMedics, Inc.: PMA supplement approved for Organ Care System (OCS™) Liver
• TransMedics, Inc.: PMA supplement approved for Organ Care System (OCS™) Lung System
• ZOLL Medical Corporation: PMA supplement approved for AED 3 Defibrillator with Uni-Padz
• ZOLL Medical Corporation: PMA supplement approved for AED 3; CPR Uni-Padz
• ZOLL Medical Corporation: PMA supplement approved for CPR Uni-padz Electrode

Minnesota

• ABBOTT MEDICAL: PMA supplement approved for Ampere Generator
• ABBOTT MEDICAL: PMA supplement approved for Amplatzer™ Amulet™ Left Atrial Appendage Occluder
• ABBOTT MEDICAL: PMA supplement approved for Current™ PFA Generator – TactiFlex Duo
• ABBOTT MEDICAL: PMA supplement approved for Epic Elite Mitral; Epic Elite Aortic; Epic Supra G3 valves
• ABBOTT MEDICAL: PMA supplement approved for Navitor™ TAVI System with Vision Technology
• ABBOTT MEDICAL: PMA supplement approved for Navitor Transcatheter Aortic Valve Implantation System
• ABBOTT MEDICAL: PMA supplement approved for TactiFlex™ Ablation Catheter, Sensor Enabled™
• ABBOTT MEDICAL: PMA supplement approved for TactiFlex™ Ablation Catheter, Sensor Enabled™, TactiSys™ Quartz Equipment, TactiSys™ Quart
• ABBOTT MEDICAL: PMA supplement approved for TactiFlex™ Duo Ablation Catheter, Sensor Enabled™ (A-TFDM-D, A-TFDM-F, A-TFDM-J, A-TFDM-DD
• ABBOTT MEDICAL: PMA supplement approved for TactiFlex™ Sensor Enabled™ Ablation Catheter
• ABBOTT MEDICAL: PMA supplement approved for TactiSys Quartz Equipment; Ampere Generator
• ABBOTT MEDICAL: PMA supplement approved for Volt™ PFA System
• ABBOTT MEDICAL: PMA supplement approved for Volt™ PFA System
• Boston Scientific Corp: PMA supplement approved for ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, (INSIGNIA and ALTRUA 2
• Boston Scientific Corp: PMA supplement approved for COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, V
• Boston Scientific Corp: PMA supplement approved for ROTAPRO™ Rotational Atherectomy Systems
• Boston Scientific Corp: PMA supplement approved for Tachy Pulse Generators
• Boston Scientific Corp: PMA supplement approved for WATCHMAN FLX™ Left Atrial Appendage Closure Device with Delivery System; WATCHMAN FLX™ Pro
• Boston Scientific Corp: PMA supplement approved for WATCHMAN FLX™ Left Atrial Appendage Closure Device with Delivery System; WATCHMAN FLX™ Pro
• Boston Scientific Corporation: PMA supplement approved for EMBLEM S-ICD
• Boston Scientific Corporation: PMA supplement approved for EMBLEM™ S-ICD Electrode (Lead) Model 3501
• Boston Scientific Corporation: PMA supplement approved for POLARx and POLARx Cryoablation Balloon Catheters; POLARSHEATH Steerable Sheaths; SMARTFREE
• Boston Scientific Corporation: PMA supplement approved for Ranger™ Paclitaxel-Coated Balloon Catheter
• Boston Scientific Corporation: PMA supplement approved for Ranger™ Paclitaxel-Coated PTA Balloon Catheter
• Coloplast Corp.: PMA supplement approved for Titan Inflatable Penile Prosthesis (IPP)
• DiaSorin, Inc.: PMA approval for LIAISON Biotrin Parvovirus B19 IgM Plus, LIAISON Biotrin Control Parvovirus B19 IgM Plus
• DiaSorin, Inc.: PMA supplement approved for LIAISON Biotrin Parvovirus B19 IgG Plus; LIAISON Biotrin Control Parvovirus B19 IgG Plus
• DiaSorin, Inc.: PMA supplement approved for LIAISON QuantiFERON-TB Gold III; LIAISON Control QuantiFERON-TB Gold III; LIAISON QuantiFE
• DiaSorin, Inc.: PMA supplement approved for LIAISON QuantiFERON-TB Gold Plus; LIAISON XL Control QuantiFERON-TB Gold Plus; LIAISON Qua
• Envoy Medical Corporation: PMA supplement approved for Esteem®
• Guidant Corp.: PMA supplement approved for INVIVE, INTUA, VISIONIST, VALITUDE
• Inspire Medical Systems: PMA supplement approved for INSPIRE II UPPER AIRWAY STIMULATOR
• Inspire Medical Systems: PMA supplement approved for Model 3150 Implantable Pulse Generator (IPG)
• Inspire Medical Systems: PMA supplement approved for Model 4063 Inspire Stimulation Lead
• Lutonix: PMA supplement approved for Lutonix™ 018 Drug Coated Balloon PTA Catheter
• Lutonix: PMA supplement approved for Lutonix™ 035 Drug Coated Balloon Catheter
• Medtronic Cardiac Rhythm Disease Management: PMA supplement approved for Amplia MRI CRT-D DTMB1D4 Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ Brava CRT-D DTBC1D4 Brava
• Medtronic Cardiac Rhythm Disease Management: PMA supplement approved for Evera MRI ICD DDMB1D4, DDMC3D4, DVMB1D4, DVMC3D4 Evera S DR ICD DDBC3D4 Evera S VR ICD DVB
• Medtronic Cardiac Rhythm Disease Management: PMA supplement approved for SelectSecure Lead Model 3830
• Medtronic Cryocath, LP: PMA supplement approved for Stop AF First
• Medtronic Cryocath, LP: PMA supplement approved for STOP Persistent AF
• Medtronic, Inc.: PMA supplement approved for Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™
• Medtronic, Inc.: PMA supplement approved for Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™
• Medtronic, Inc.: PMA supplement approved for Affera Ablation System
• Medtronic, Inc.: PMA supplement approved for Astra S DR MRI IPG (X3DR01);Astra S SR MRI IPG (X3SR01);Astra XT DR MRI IPG (X1DR01); Astr
• Medtronic, Inc.: PMA supplement approved for Aurora EV ICD DVEA3E4
• Medtronic, Inc.: PMA supplement approved for CareLink SmartSync™ Adapta™ Versa™ Sensia™ Application (D00U014)
• Medtronic, Inc.: PMA supplement approved for CareLink SmartSync Platform Application (M01A01); CareLink SmartSync Common Application (M
• Medtronic, Inc.: PMA supplement approved for HexaGen RF Generator Software and Remote
• Medtronic, Inc.: PMA supplement approved for Medtronic Evolut PRO+ Transcatheter Aortic Valve Replacement System; Medtronic Evolut FX T
• Medtronic, Inc.: PMA supplement approved for Melody Transcatheter Pulmonary Valve System, which includes the Melody Transcatheter Pulmo
• Medtronic, Inc.: PMA supplement approved for Micra™ Scalable Catheter Delivery System (Micra AV TPS MC1AVR1; Micra AV2 TPS MC2AVR1; Mic
• Medtronic, Inc.: PMA supplement approved for Percepta Bipolar CRT-P (WlTR0l); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRT-P
• Medtronic, Inc.: PMA supplement approved for Sphere-9 Catheter™ and Affera™ Ablation System
• Medtronic, Inc.: PMA supplement approved for Sphere-9 Catheter and Affera Ablation System
• Medtronic, Inc.: PMA supplement approved for Sphere-9 Catheter and Affera Ablation System
• Medtronic: PMA supplement approved for HeartWare™ HVAD™ System
• Medtronic: PMA supplement approved for HeartWare® HVAD System
• Medtronic: PMA supplement approved for HeartWare® Ventricular Assist System
• St Jude Medical: PMA supplement approved for Ampere Generator
• St Jude Medical: PMA supplement approved for TactiSys Quartz Equipment; Ampere Generator

Missouri

• Geneoscopy, Inc.: PMA supplement approved for ColoSense®
• Geneoscopy, Inc.: PMA supplement approved for ColoSense®
• Medibeacon, Inc.: PMA supplement approved for MediBeacon Transdermal GFR System
• Medibeacon, Inc.: PMA supplement approved for MediBeacon® Transdermal GFR Measurement System (TGFR)
• Stereotaxis, Inc.: PMA supplement approved for MAGiC Ablation Catheter

New Hampshire

• Atrium Medical Corp.: PMA supplement approved for iCast Covered Stent System

New Jersey

• ETHICON, Inc.: PMA supplement approved for ETHIZIA™ Hemostatic Patch
• ETHICON, Inc.: PMA supplement approved for ETHIZIA Hemostatic Patch
• ETHICON, Inc.: PMA supplement approved for SURGICELTM POWDER Absorbable Hemostatic Powder
• Impulse Dynamics (Usa), Inc.: PMA supplement approved for OPTIMIZER Smart System

New York

• Bausch & Lomb, Inc.: PMA supplement approved for enVista Envy™ hydrophobic acrylic intraocular lens (IOL), enVista Envy™ toric hydrophobic
• NuMED, Inc.: PMA supplement approved for CP Stent (Model 425), Covered CP Stent (Model 427), Mounted CP Stent (Model 426), Covered
• Siemens Healthcare Diagnostics, Inc.: PMA approval for Atellica IM free PSA II (fPSAII)
• Siemens Healthcare Diagnostics, Inc.: PMA supplement approved for Atellica IM Total PSA II (tPSAII)

North Carolina

• Merz North America, Inc.: PMA approval for Belotero Volume (+) Lidocaine
• Merz North America, Inc.: PMA approval for Belotero® Intense (+) Lidocaine
• Merz North America, Inc.: PMA supplement approved for Belotero® Intense (+) Lidocaine

Ohio

• AtriCure, Inc.: PMA supplement approved for EPi-Sense and EPi-Sense ST Guided Coagulation System
• AtriCure, Inc.: PMA supplement approved for Synergy Ablation System
• Cleveland Diagnostics, Inc.: PMA supplement approved for IsoPSA® Assay

Oregon

• Biotronik Nro, Inc.: PMA supplement approved for Prospera Spinal Cord Stimulation (SCS) System, Resilience Percutaneous Lead, HomeStream Re
• Biotronik, Inc.: PMA supplement approved for Acticor Sky DR-T 481987; Rivacor Sky DR-T 481982; Rivacor Rise DR-T 482018; Rivacor Aura D
• Biotronik, Inc.: PMA supplement approved for Acticor Sky HF-T 481986; Rivacor Sky HF-T 481991; Rivacor Rise HF-T 482017; Rivacor Aura H
• Biotronik, Inc.: PMA supplement approved for Acticor Sky VR-T 481989; Rivacor Sky VR-T 481984; Rivacor Rise VR-T 482020; Rivacor Aura V
• Biotronik, Inc.: PMA supplement approved for Acticor Sky VR-T, Rivacor Sky VR-T, Rivacor Rise VR-T, Rivacor Aura VR-T, Acticor Sky VR-T
• Biotronik, Inc.: PMA supplement approved for BIOexpress
• Biotronik, Inc.: PMA supplement approved for BIOexpress
• Biotronik, Inc.: PMA supplement approved for BIOexpress
• Biotronik, Inc.: PMA supplement approved for BIOexpress
• Biotronik, Inc.: PMA supplement approved for Edora 8 DR-T 407145, Evity 8 DR-T 407146, Enitra 8 DR-T 407147, Enticos 8 DR-T 407148, Evi
• Biotronik, Inc.: PMA supplement approved for Edora 8 DR-T 407145; Evity 8 DR-T 407146; Enitra 8 DR-T 407147; Enticos 8 DR-T 407148; Evi
• Biotronik, Inc.: PMA supplement approved for Edora 8 HF-T QP 407137 Edora 8 HF-T 407138 Evity 8 HF-T QP 407139 Evity 8 HF-T 407140 Enit
• Biotronik, Inc.: PMA supplement approved for Edora 8 HF-T QP 407137; Edora 8 HF-T 407138; Evity 8 HF-T QP 407139; Evity 8 HF-T 407140;
• Biotronik, Inc.: PMA supplement approved for Ilivia 7 VR-T DX 404624; Intica 7 VR-T DX 404633; Intica 5 VR-T DX 404688; Ilivia 7 VR-T 4
• Biotronik, Inc.: PMA supplement approved for Ilivia Neo 7 DR-T 429529; Intica Neo 7 DR-T 429558; Intica Neo 5 DR-T 429568
• Biotronik, Inc.: PMA supplement approved for Ilivia Neo 7 VR-T DX 429530; Intica Neo 7 VR-T DX 429559; Intica Neo 5 VR-T DX 429569
• Biotronik, Inc.: PMA supplement approved for PSW 2601.U, NEO 2601.U
• Biotronik, Inc.: PMA supplement approved for PSW 2601.U, NEO 2601.U, Acticor Sky DR-T, Rivacor Sky DR-T, Rivacor Rise DR-T, Rivacor Aur
• Biotronik, Inc.: PMA supplement approved for PSW 2601.U, NEO 2601.U, Acticor Sky HF-T, Rivacor Sky HF-T, Rivacor Rise HF-T, Rivacor Aur
• Biotronik, Inc.: PMA supplement approved for PSW 2601.U, NEO 2601.U, Amvia Sky HF-T QP, Amvia Sky HF-T, Amvia Edge HF-T QP, Amvia Sky D

Pennsylvania

• Centinel Spine, LLC: PMA supplement approved for prodisc® C Nova
• Lungpacer Medical USA, Inc.: PMA supplement approved for AeroPace® System
• Lungpacer Medical USA, Inc.: PMA supplement approved for AeroPace® System
• Lungpacer Medical USA, Inc.: PMA supplement approved for AeroPace® System
• Siemens Medical Solutions USA, Inc.: PMA supplement approved for MAMMOMAT B.brilliant with Tomosynthesis Option
• Tiger Aesthetics Medical, LLC: PMA supplement approved for SANAE®
• Zoll Manufacturing Corporation: PMA supplement approved for LifeVest® Wearable Defibrillator

Tennessee

• Cyndrx, LLC: PMA approval for AbsorbaSeal 5.6.7F Vascular Closure Device
• Lynch Biologics, LLC: PMA supplement approved for GEM21S® Growth Factor Enhanced Matrix Implementation of Restricted Access Barrier System (
• Medtronic Sofamor Danek USA, Inc.: PMA supplement approved for Infuse™ Bone Graft
• Medtronic Sofamor Danek USA, Inc.: PMA supplement approved for INFUSE BONE GRAFT
• Medtronic Sofamor Danek USA, Inc.: PMA supplement approved for INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE
• Medtronic Sofamor Danek USA, Inc.: PMA supplement approved for Infuse TM Bone Graft/Medtronic lnterbody Fusion Device
• Medtronic, Inc.: PMA supplement approved for Infuse™ Bone Graft
• Medtronic, Inc.: PMA supplement approved for INFUSE BONE GRAFT

Texas

• ABBOTT MEDICAL: PMA supplement approved for Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG)
• ABBOTT MEDICAL: PMA supplement approved for Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG)
• ABBOTT MEDICAL: PMA supplement approved for Infinity DBS IPG
• ABBOTT MEDICAL: PMA supplement approved for Proclaim DRG IPG
• ABBOTT MEDICAL: PMA supplement approved for Proclaim family of SCS IPG
• ABBOTT MEDICAL: PMA supplement approved for Quattrode®; Octrode™; Penta™; Lamitrode™; Tripole™; TriCentrus™ Lead Extensions
• ABBOTT MEDICAL: PMA supplement approved for Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG)
• Alcon Laboratories, LLC: PMA supplement approved for Clareon Aspheric Hydrophobic Acrylic Intraocular Lens with the AutonoMe Pre- Loaded Delive
• Alcon Laboratories, LLC: PMA supplement approved for Clareon Vivity™ Toric Extended Vision UV Absorbing Hydrophobic Intraocular Lens (IOL)
• Alcon Laboratories: PMA supplement approved for VISCOAT Ophthalmic Viscosurgical Device; DUOVISC Ophthalmic Viscoelastic System.
• Alcon Research, Ltd.: PMA supplement approved for PROVISC Ophthalmic Viscosurgical Device
• Berlin Heart, Inc.: PMA supplement approved for EXCOR Pediatric VAD
• Berlin Heart, Inc.: PMA supplement approved for EXCOR Pediatric Ventricular Assist Device
• Berlin Heart, Inc.: PMA supplement approved for EXCOR Pediatric Ventricular Assist Device
• LivaNova USA, Inc.: PMA supplement approved for aura6000™ system
• LivaNova USA, Inc.: PMA supplement approved for VNS Therapy System
• LivaNova USA, Inc.: PMA supplement approved for VNS Therapy® System
• Natera, Inc.: PMA approval for Signatera™ CDx

Utah

• Bunnell, Inc.: PMA supplement approved for LifePulse® High Frequency Ventilator

Virginia

• Dilon Technologies, Inc.: PMA supplement approved for HEMOBLAST™ Bellows
• Theragen, Inc.: PMA supplement approved for ActaStim-S

Washington

• Gyrus Acmi, Inc.: PMA supplement approved for Spiration® Valve System
• Philips Medical Systems, Inc.: PMA supplement approved for HeartStart FR3 Text (861388) Defibrillator; HeartStart FR3 ECG (861389) Defibrillator
• Philips Medical Systems: PMA supplement approved for HeartStart FRx Defibrillator (861304)
• Physio-Control, Inc.: PMA supplement approved for LIFEPAK® 15 monitor/defibrillator
• Physio-Control, Inc.: PMA supplement approved for LIFEPAK® 35 monitor/defibrillator
• Physio-Control, Inc.: PMA supplement approved for LIFEPAK® 35 monitor/defibrillator

Wisconsin

• Exact Sciences Corporation: PMA supplement approved for Cologuard Plus™
• Exact Sciences Corporation: PMA supplement approved for Cologuard Plus™
• Exact Sciences Corporation: PMA supplement approved for Cologuard®
• Merz North America, Inc.: PMA supplement approved for Belotero Balance Dermal Filler; Belotero Balance (+) Lidocaine
• Promega Corporation: PMA approval for OncoMate® MSI Dx Analysis System

Wyoming

• Endospan , Ltd.: PMA supplement approved for NEXUS Aortic Arch Stent Graft System
• Endospan , Ltd.: PMA supplement approved for NEXUS Aortic Arch Stent Graft System

Browse FdaApprovalPulse by category and location · Search and filter FdaApprovalPulse