device pma
saveEdwards Lifesciences, LLC — INSPIRIS RESILIA Aortic Valve; MITRIS RESILIA Mitral Valve (PMA supplement)
community read0 votes
Supplement type: 30-Day Notice. Product code: LWR. 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 SAPIEN 3 Transcatheter Heart Valve; Edwards SAPIEN 3 Ultra Transcatheter Heart Valve; Edwards SAPIEN 3 Ultra RES (PMA supplement)Oct 16, 2025
- device pmaEdwards Lifesciences, LLC — Edwards SAPIEN 3 Transcatheter Heart Valve (PMA supplement)Oct 16, 2025
- device pmaEdwards Lifesciences, LLC — Carpentier-Edwards PERIMOUNT RSR Pericardial Aortic Bioprosthesis; Carpentier-Edwards PERIMOUNT Plus Mitral Bioprosthesi (PMA supplement)Oct 16, 2025
- device pmaEdwards Lifesciences, LLC — EDWARDS INTUITY Elite Valve (PMA supplement)Oct 16, 2025
- device 510kEdwards Lifesciences — HemoSphere Stream Module (510k cleared)Oct 21, 2025
- device pmaEdwards Lifesciences, LLC — SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES (PMA supplement)Oct 10, 2025
comments(0)
5-min edit window · permanent after that