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 2026-11-03; each record links to its official source and a full report.
Data as of · Compiled by Zalwin from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)
Includes: Sponsor, Product, Approval, Decided, official source URL and score · Card, Apple Pay, Google Pay or Link via Stripe
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 2026-11-03. Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration).
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- ABBOTT MEDICAL (42)
- Biotronik, Inc. (19)
- Medtronic, Inc. (19)
- Boston Scientific Corp (15)
- Edwards Lifesciences, LLC (12)
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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 | 🔒 Unlock all 367 records → | ||
| Biotronik, Inc. | 🔒 Unlock all 367 records → | ||
| Endotronix, Inc. | 🔒 Unlock all 367 records → | ||
Browse 35 more matching record reports
- Mainstay Medical Limited
- Biotronik, Inc.
- Endotronix, Inc.
- Biotronik, Inc.
- Lung Bioengineering, Inc.
- ZOLL Medical Corporation
- Biotronik, Inc.
- Biotronik, Inc.
- Balt USA, LLC
- Lung Bioengineering, Inc.
- Boston Scientific Corp
- ABBOTT MEDICAL
- Berlin Heart, Inc.
- Ev3 Neurovascular
- Med-El Corp.
- Biotronik, Inc.
- Organox Limited
- Biotronik, Inc.
- Biotronik, Inc.
- Biotronik, Inc.
- Biotronik, Inc.
- Ventana Medical Systems
- Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)
- W. L. Gore & Associates, Inc.
- Croma-Pharma GmbH
- Croma-Pharma GmbH
- Medtronic, Inc.
- Medtronic, Inc.
- Medtronic, Inc.
- LivaNova USA, Inc.
- Medibeacon, Inc.
- Motiva USA, LLC
- Berlin Heart, Inc.
- Pramand, LLC
- ABBOTT MEDICAL
More records in this hub: page 2 · page 3 · page 4
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Which related categories and locations should I check?
Browse by approval type
Drug labeling or REMS supplement (1174) Generic drug approval (ANDA) (194) Drug efficacy supplement (new indication or use) (76) Drug manufacturing (CMC) supplement (55) New drug application (NDA) (40) PMA original approval (new class III device) (24) Biologic license (BLA) (17) Other drug supplement (12)
Browse by sponsor state (devices)
California (110) Minnesota (61) Massachusetts (37) Oregon (20) Arizona (18) Texas (18) Illinois (9) Maryland (9) Tennessee (8) Pennsylvania (7) Florida (6) Washington (6) Missouri (5) Wisconsin (5) Colorado (4) Connecticut (4) Georgia (4) Indiana (4) New Jersey (4) New York (4) North Carolina (3) Ohio (3)
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