device pma
saveAbiomed, Inc. — Impella 5.5 with SmartAssist (PMA supplement)
October 1, 2025updated 5mo ago
community read0 votes
Supplement type: 30-Day Notice. Product code: OZD. Advisory committee: CV. Decision: OK30
view source ↗Data sources
last refreshed 5mo ago
Found something off?
same company · ±60 days · 6
- device recallAbiomed, Inc. device recall (Cls I)Oct 1, 2025
- device 510kAbiomed, Inc. — 14Fr Low Profile Introducer Kit (510k cleared)Oct 8, 2025
- device pmaAbiomed, Inc. — Impella CP with SmartAssist (PMA supplement)Sep 24, 2025
- device pmaAbiomed, Inc. — Impella RP, Impella RP with SmartAssist, Impella RP Flex with SmartAssist (PMA supplement)Sep 19, 2025
- device pmaAbiomed, Inc. — Impella 2.5; Impella CP; Impella CP with SmartAssist; Impella 5.0; Impella 5.5 with SmartAssist; Impella LD (PMA supplement)Sep 19, 2025
- device recallAbiomed, Inc. device recall (Cls I)Sep 16, 2025
comments(0)
5-min edit window · permanent after that