- [Home](/) › - [FdaApprovalPulse](/v/fdaapprovalpulse) › - [Hubs](/hub/fdaapprovalpulse) › - PMA supplement (device change) # FdaApprovalPulse: PMA supplement (device change) **367 fdaApprovalPulse: PMA supplement (device change) are listed from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration), dated 2026-05-01 to 2026-10-23; the most frequent is ABBOTT MEDICAL with 42. Data last updated 2026-11-04; each record links to its official source and a full report.** Data as of 2026-11-04 · [Compiled by Zalwin](/research/fdaapprovalpulse) from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration) Copy citation Download all 367 fdaApprovalPulse: PMA supplement (device change) (CSV) — $4.99 → Includes: Sponsor, Product, Approval, Decided, official source URL and score · Card, Apple Pay, Google Pay or Link via Stripe [Free sample: 3 records (CSV)](/v1/verticals/fdaapprovalpulse/records.csv?type=pma_supplement) 367 records from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration), dated 2026-05-01 to 2026-10-23. Most frequent: ABBOTT MEDICAL (42). Each record links to a full report and the official source. Last updated 2026-11-04. Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration). **Search, filter and export FdaApprovalPulse records** [Run instant live search with these filters](/v/fdaapprovalpulse?type=pma_supplement&channel=pseo#vt-out) [Download free 3-row sample CSV](/v1/verticals/fdaapprovalpulse/records.csv?type=pma_supplement) Unlock the full CSV for these filters — $4.99 → ✓ Read-only, live public data · Key and unlock right after payment · Card, Apple Pay, Google Pay or Link via Stripe · Refunds on request within 14 days ## Get new FdaApprovalPulse records by email (free, weekly) We email one confirmation link now; the weekly digest starts only after you confirm. One-click unsubscribe in every email. Double opt-in: nothing is sent until you click the confirmation link. One-click unsubscribe. [See this week's digest](/digest/fdaapprovalpulse) Records 367 Most frequent - ABBOTT MEDICAL (42) - Biotronik, Inc. (19) - Medtronic, Inc. (19) - Boston Scientific Corp (15) - Edwards Lifesciences, LLC (12) ## How do I get new fdaApprovalPulse: PMA supplement (device change) by email? Search, filter and export these records, or get alerts when new ones appear. [Search and filter](/v/fdaapprovalpulse?type=pma_supplement) [Watch this exact filter](/v/fdaapprovalpulse?type=pma_supplement#more-ways) [See alert plans](/v/fdaapprovalpulse#pricing) ## What are the top fdaApprovalPulse: PMA supplement (device change) right now? | Record | Product | Approval | Decided | |---|---|---|---| | Instylla, Inc. | Embrace(TM) Hydrogel Embolic System | PMA supplement (device change) | 2026-10-23 | | Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) | VENTANA MET (SP44) RxDx Assay | PMA supplement (device change) | 2026-10-23 | | Cerenovus, Inc. | TRUFILL n-BCA Liquid Embolic System | PMA supplement (device change) | 2026-10-23 | | Advanced Medical Solutions Limited | LIQUIFIX FIX8 Laparoscopic Hernia Mesh Fixation (HMF) Device; LIQUIFIX Precision Open Hernia Mesh Fixation Device | PMA supplement (device change) | 2026-10-23 | | Lenstec, Inc. | ClearView™ HD intraocular lens (IOL) | PMA supplement (device change) | 2026-10-23 | | Instylla, Inc. | Embrace® Hydrogel Embolic System | PMA supplement (device change) | 2026-10-23 | | Edwards Lifesciences, LLC | PASCAL Precision Transcatheter Valve Repair System | PMA supplement (device change) | 2026-10-22 | | Edwards Lifesciences, LLC | INSPIRIS RESILIA Aortic Valve; MITRIS RESILIA Mitral Valve | PMA supplement (device change) | 2026-10-22 | | Edwards Lifesciences, LLC | Edwards SAPIEN 3 Ultra™ RESILIA Transcatheter Heart Valve | PMA supplement (device change) | 2026-10-22 | | Edwards Lifesciences, LLC | EVOQUE Tricuspid Valve Replacement System | PMA supplement (device change) | 2026-10-21 | | Boston Scientific Corp | ROTAPRO™ Rotational Atherectomy Systems | PMA supplement (device change) | 2026-10-21 | | Instylla, Inc. | Embrace(TM) Hydrogel Embolic System | PMA supplement (device change) | 2026-10-21 | | ABBOTT MEDICAL | AVEIR VR Real-World Evidence Study | PMA supplement (device change) | 2026-10-21 | | Edwards Lifesciences, LLC | PASCAL Precision Transcatheter Valve Repair System | PMA supplement (device change) | 2026-10-20 | | Edwards Lifesciences, LLC | Edwards EVOQUE Tricuspid Valve Replacement System | PMA supplement (device change) | 2026-10-19 | | Mainstay Medical Limited | Included in the full CSV with every column 🔒 Unlock all 367 records → | | Biotronik, Inc. | Included in the full CSV with every column 🔒 Unlock all 367 records → | | Endotronix, Inc. | Included in the full CSV with every column 🔒 Unlock all 367 records → | Browse 35 more matching record reports - [Mainstay Medical Limited](/report/fdaapprovalpulse/mainstay-medical-limited-swords-co-dublin--pma-p190021-s012) - [Biotronik, Inc.](/report/fdaapprovalpulse/biotronik-inc-lake-oswego-or--pma-p050023-s209) - [Endotronix, Inc.](/report/fdaapprovalpulse/endotronix-inc-naperville-il--pma-p230040-s031) - [Biotronik, Inc.](/report/fdaapprovalpulse/biotronik-inc-lake-oswego-or--pma-p000009-s128) - [Lung Bioengineering, Inc.](/report/fdaapprovalpulse/lung-bioengineering-inc-silver-spring-md--pma-p240033-s001) - [ZOLL Medical Corporation](/report/fdaapprovalpulse/zoll-medical-corporation-chelsmford-ma--pma-p160015-s029) - [Biotronik, Inc.](/report/fdaapprovalpulse/biotronik-inc-lake-oswego-or--pma-p070008-s177) - [Biotronik, Inc.](/report/fdaapprovalpulse/biotronik-inc-lake-oswego-or--pma-p950037-s289) - [Balt USA, LLC](/report/fdaapprovalpulse/balt-usa-llc-irvine-ca--pma-p250009-s001) - [Lung Bioengineering, Inc.](/report/fdaapprovalpulse/lung-bioengineering-inc-silver-spring-md--pma-p240033-s002) - [Boston Scientific Corp](/report/fdaapprovalpulse/boston-scientific-corp-valencia-ca--pma-p150031-s100) - [ABBOTT MEDICAL](/report/fdaapprovalpulse/abbott-medical-plymouth-mn--pma-p250022-s002) - [Berlin Heart, Inc.](/report/fdaapprovalpulse/berlin-heart-inc-the-woodlands-tx--pma-p160035-s056) - [Ev3 Neurovascular](/report/fdaapprovalpulse/ev3-neurovascular-irvine-ca--pma-p030004-s039) - [Med-El Corp.](/report/fdaapprovalpulse/med-el-corp-innsbruck--pma-p000025-s136) - [Biotronik, Inc.](/report/fdaapprovalpulse/biotronik-inc-lake-oswego-or--pma-p050023-s213) - [Organox Limited](/report/fdaapprovalpulse/organox-limited-oxford--pma-p200035-s038) - [Biotronik, Inc.](/report/fdaapprovalpulse/biotronik-inc-lake-oswego-or--pma-p000009-s132) - [Biotronik, Inc.](/report/fdaapprovalpulse/biotronik-inc-lake-oswego-or--pma-p070008-s181) - [Biotronik, Inc.](/report/fdaapprovalpulse/biotronik-inc-lake-oswego-or--pma-p980023-s149) - [Biotronik, Inc.](/report/fdaapprovalpulse/biotronik-inc-lake-oswego-or--pma-p950037-s296) - [Ventana Medical Systems](/report/fdaapprovalpulse/ventana-medical-systems-tucson-az--pma-p200019-s014) - [Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)](/report/fdaapprovalpulse/ventana-medical-systems-inc-roche-tissue-diagnostics-tucson-az--pma-p210001-s016) - [W. L. Gore & Associates, Inc.](/report/fdaapprovalpulse/w-l-gore-and-associates-inc-flagstaff-az--pma-p160021-s051) - [Croma-Pharma GmbH](/report/fdaapprovalpulse/croma-pharma-gmbh-leobendorf--pma-p250021-s002) - [Croma-Pharma GmbH](/report/fdaapprovalpulse/croma-pharma-gmbh-leobendorf--pma-p250021-s001) - [Medtronic, Inc.](/report/fdaapprovalpulse/medtronic-inc-minneapolis-mn--pma-p960009-s542) - [Medtronic, Inc.](/report/fdaapprovalpulse/medtronic-inc-mounds-view-mn--pma-p240013-s028) - [Medtronic, Inc.](/report/fdaapprovalpulse/medtronic-inc-mounds-view-mn--pma-p240013-s031) - [LivaNova USA, Inc.](/report/fdaapprovalpulse/livanova-usa-inc-houston-tx--pma-p970003-s254) - [Medibeacon, Inc.](/report/fdaapprovalpulse/medibeacon-inc-st-louis-mo--pma-p230019-s005) - [Motiva USA, LLC](/report/fdaapprovalpulse/motiva-usa-llc-santa-barbara-ca--pma-p230005-s002) - [Berlin Heart, Inc.](/report/fdaapprovalpulse/berlin-heart-inc-the-woodlands-tx--pma-p160035-s057) - [Pramand, LLC](/report/fdaapprovalpulse/pramand-llc-bedford-ma--pma-p220014-s013) - [ABBOTT MEDICAL](/report/fdaapprovalpulse/abbott-medical-atlanta-ga--pma-p100045-s091) More records in this hub: [page 2](/hub/fdaapprovalpulse/type/pma-supplement/page/2) · [page 3](/hub/fdaapprovalpulse/type/pma-supplement/page/3) · [page 4](/hub/fdaapprovalpulse/type/pma-supplement/page/4) [Browse all FdaApprovalPulse record reports](/hub/fdaapprovalpulse/records) ## Which related categories and locations should I check? ### Browse by approval type [Drug labeling or REMS supplement (1180)](/hub/fdaapprovalpulse/type/suppl-labeling) [Generic drug approval (ANDA) (196)](/hub/fdaapprovalpulse/type/anda) [Drug efficacy supplement (new indication or use) (77)](/hub/fdaapprovalpulse/type/suppl-efficacy) [Drug manufacturing (CMC) supplement (55)](/hub/fdaapprovalpulse/type/suppl-manufacturing) [New drug application (NDA) (41)](/hub/fdaapprovalpulse/type/nda) [PMA original approval (new class III device) (24)](/hub/fdaapprovalpulse/type/pma-original) [Biologic license (BLA) (17)](/hub/fdaapprovalpulse/type/bla) [Other drug supplement (12)](/hub/fdaapprovalpulse/type/suppl-other) ### Browse by sponsor state (devices) [California (110)](/hub/fdaapprovalpulse/state/ca) [Minnesota (61)](/hub/fdaapprovalpulse/state/mn) [Massachusetts (37)](/hub/fdaapprovalpulse/state/ma) [Oregon (20)](/hub/fdaapprovalpulse/state/or) [Arizona (18)](/hub/fdaapprovalpulse/state/az) [Texas (18)](/hub/fdaapprovalpulse/state/tx) [Illinois (9)](/hub/fdaapprovalpulse/state/il) [Maryland (9)](/hub/fdaapprovalpulse/state/md) [Tennessee (8)](/hub/fdaapprovalpulse/state/tn) [Pennsylvania (7)](/hub/fdaapprovalpulse/state/pa) [Florida (6)](/hub/fdaapprovalpulse/state/fl) [Washington (6)](/hub/fdaapprovalpulse/state/wa) [Missouri (5)](/hub/fdaapprovalpulse/state/mo) [Wisconsin (5)](/hub/fdaapprovalpulse/state/wi) [Colorado (4)](/hub/fdaapprovalpulse/state/co) [Connecticut (4)](/hub/fdaapprovalpulse/state/ct) [Georgia (4)](/hub/fdaapprovalpulse/state/ga) [Indiana (4)](/hub/fdaapprovalpulse/state/in) [New Jersey (4)](/hub/fdaapprovalpulse/state/nj) [New York (4)](/hub/fdaapprovalpulse/state/ny) [North Carolina (3)](/hub/fdaapprovalpulse/state/nc) [Ohio (3)](/hub/fdaapprovalpulse/state/oh) ## Frequently asked questions ### How many fdaApprovalPulse: PMA supplement (device change) are listed? 367 records from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration), last refreshed automatically. The most recent is dated 2026-10-23. ### Can I get alerts for PMA supplement (device change)? Yes. FdaApprovalPulse can email you new records matching this filter; plans are listed on the FdaApprovalPulse page. Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration). Informational only. [RSS feed of new records](/feed/fdaapprovalpulse.xml) ## Often used together - [FDAPulse](/v/fdapulse) - [FdaNdcDirectoryPulse](/v/fdandcdirectorypulse) - [NycPropertyExemptionDetailPulse](/v/nycpropertyexemptiondetailpulse) - [MigrationRedirectAudit](/migrationredirectaudit) - [SchemaMarkupGeneratorKit](/schemageneratorkit) - [ShopifyStorefrontXray](/shopifystorefrontxray)