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 Commander Delivery System (9600LDS20, 9600LDS23, 9600LDS26, 9600LDS29, 9750CM20, 9750CM23, 9750CM26) (PMA supplement)Jul 8, 2025
- device pmaEdwards Lifesciences, LLC — Edwards Commander Delivery System (9600LDS20, 9600LDS23, 9600LDS26, 9600LDS29) (PMA supplement)Jul 8, 2025
- device pmaEdwards Lifesciences, LLC — Edwards EVOQUE tricuspid delivery system (PMA supplement)Jul 23, 2025
- device 510kEdwards Lifesciences — HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere ClearSight Module (HEMCSM10); Smart Pressure Controller (PC1Q); Acumen IQ Plus Finger Cuff (AIQCA2); HemoSphere Pressure Cable (HEMPSC100); HemoSphere Vita Monitor (HEMVITA1); HemoSphere Vita Technology Module (HEMVTOM1); HemoSphere VitaWave module (HEMVWM1); VitaWave Plus finger cuff (VWCA2) (510k cleared)Jul 23, 2025
- device pmaEdwards Lifesciences, LLC — PASCAL Precision Transcatheter Valve Repair System (PMA supplement)Jul 25, 2025
- device pmaEdwards Lifesciences, LLC — Edwards Commander Delivery System (PMA supplement)Jun 26, 2025
comments(0)
5-min edit window · permanent after that