- [Home](/) › - [FdaApprovalPulse](/v/fdaapprovalpulse) › - [Hubs](/hub/fdaapprovalpulse) › - PMA original approval (new class III device) # FdaApprovalPulse: PMA original approval (new class III device) **24 fdaApprovalPulse: PMA original approval (new class III device) are listed from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration), dated 2026-05-07 to 2026-10-16; the most frequent is Merz North America, Inc. with 2. 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 24 fdaApprovalPulse: PMA original approval (new class III device) (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_original) 24 records from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration), dated 2026-05-07 to 2026-10-16. Most frequent: Merz North America, Inc. (2). 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_original&channel=pseo#vt-out) [Download free 3-row sample CSV](/v1/verticals/fdaapprovalpulse/records.csv?type=pma_original) 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 24 Most frequent - Merz North America, Inc. (2) - Vivasure Medical , Ltd. (1) - Edwards Lifesciences, LLC (1) - Rejoni, Inc. (1) - Bard Peripheral Vascular, Inc. (1) ## How do I get new fdaApprovalPulse: PMA original approval (new class III device) by email? Search, filter and export these records, or get alerts when new ones appear. [Search and filter](/v/fdaapprovalpulse?type=pma_original) [Watch this exact filter](/v/fdaapprovalpulse?type=pma_original#more-ways) [See alert plans](/v/fdaapprovalpulse#pricing) ## What are the top fdaApprovalPulse: PMA original approval (new class III device) right now? | Record | Product | Approval | Decided | |---|---|---|---| | Vivasure Medical , Ltd. | PerQseal® Elite Vascular Closure Device | PMA original approval (new class III device) | 2026-10-16 | | Edwards Lifesciences, LLC | Autus Size-Adjustable Valve | PMA original approval (new class III device) | 2026-10-01 | | Rejoni, Inc. | Juveena Hydrogel System | PMA original approval (new class III device) | 2026-09-28 | | Bard Peripheral Vascular, Inc. | Liverty™ TIPS Stent Graft | PMA original approval (new class III device) | 2026-09-25 | | MedAlliance, LLC | SELUTION SLR™ 014 PTCA Drug-Eluting Balloon | PMA original approval (new class III device) | 2026-09-18 | | Promega Corporation | OncoMate® MSI Dx Analysis System | PMA original approval (new class III device) | 2026-09-15 | | Implantica CE Reflux , Ltd. | RefluxStop® Device and RefluxStop® Deployment Tool | PMA original approval (new class III device) | 2026-08-20 | | Spineart USA, Inc. | BAGUERA®C Cervical Disc Prosthesis | PMA original approval (new class III device) | 2026-08-10 | | Tianjin MasterVision Technology Co., Ltd. | DilightTM (roflufocon E) Overnight Orthokeratology Contact Lens | PMA original approval (new class III device) | 2026-08-05 | | Personal Genome Diagnostics, Inc. | PGDx elio tissue complete CDx | PMA original approval (new class III device) | 2026-07-30 | | Freenome, LLC | SimpleScreen™ CRC | PMA original approval (new class III device) | 2026-07-24 | | Traferox Technologies, Inc. | TorEx Lung Perfusion System | PMA original approval (new class III device) | 2026-07-15 | | Merz North America, Inc. | Belotero® Intense (+) Lidocaine | PMA original approval (new class III device) | 2026-07-09 | | Artivion, Inc. | AMDS Hybrid Prosthesis | PMA original approval (new class III device) | 2026-06-26 | | Lung Bioengineering, Inc. | LungFX™ device | PMA original approval (new class III device) | 2026-06-22 | | Hepquant, LLC | Included in the full CSV with every column 🔒 Unlock all 24 records → | | Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) | Included in the full CSV with every column 🔒 Unlock all 24 records → | | Croma-Pharma GmbH | Included in the full CSV with every column 🔒 Unlock all 24 records → | Browse 9 more matching record reports - [Hepquant, LLC](/report/fdaapprovalpulse/hepquant-llc-aurora-co--pma-p220016-orig) - [Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)](/report/fdaapprovalpulse/ventana-medical-systems-inc-roche-tissue-diagnostics-tucson-az--pma-p250031-orig) - [Croma-Pharma GmbH](/report/fdaapprovalpulse/croma-pharma-gmbh-leobendorf--pma-p250021-orig) - [Cyndrx, LLC](/report/fdaapprovalpulse/cyndrx-llc-brentwood-tn--pma-p230038-orig) - [Guardant Health, Inc.](/report/fdaapprovalpulse/guardant-health-inc-redwood-city-ca--pma-p250027-orig) - [Merz North America, Inc.](/report/fdaapprovalpulse/merz-north-america-inc-raleigh-nc--pma-p250020-orig) - [Natera, Inc.](/report/fdaapprovalpulse/natera-inc-austin-tx--pma-p260004-orig) - [Siemens Healthcare Diagnostics, Inc.](/report/fdaapprovalpulse/siemens-healthcare-diagnostics-inc-tarrytown-ny--pma-p250026-orig) - [DiaSorin, Inc.](/report/fdaapprovalpulse/diasorin-inc-stillwater-mn--pma-p250039-orig) [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) [PMA supplement (device change) (367)](/hub/fdaapprovalpulse/type/pma-supplement) [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) [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 original approval (new class III device) are listed? 24 records from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration), last refreshed automatically. The most recent is dated 2026-10-16. ### Can I get alerts for PMA original approval (new class III device)? 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)