device pma
saveEdwards Lifesciences, LLC — PASCAL Precision Transcatheter Valve Repair System (PMA supplement)
community read0 votes
Supplement type: 30-Day Notice. Product code: NKM. Advisory committee: CV. Decision: OK30
view source ↗Data sources
last refreshed 5mo ago
Found something off?
same company · ±60 days · 6
- device pmaEdwards Lifesciences, LLC — Edwards EVOQUE tricuspid delivery system (PMA supplement)Sep 12, 2025
- device 510kEdwards Lifesciences, LLC — Carpentier-Edwards Physio Annuloplasty Ring (4450) (510k cleared)Sep 17, 2025
- device 510kEdwards Lifesciences — Edwards eSheath Optima introducer set (510k cleared)Aug 29, 2025
- device 510kEdwards Lifesciences, LLC — Edwards MC3 Tricuspid annuloplasty ring (4900) (510k cleared)Sep 23, 2025
- device pmaEdwards Lifesciences, LLC — Edwards EVOQUE Tricuspid Valve Replacement System (PMA supplement)Sep 25, 2025
- device pmaEdwards Lifesciences, LLC — Edwards Commander Delivery System: 9600LDS23, 9600LDS26, 9600LDS29 9750CM23, 9750CM26, 9750CM29 (PMA supplement)Oct 2, 2025
comments(0)
5-min edit window · permanent after that