Catalysts for Abion Inc
30 tracked
Apr 7, 2026
device pma
Abiomed, Inc. — Impella 5.5 with Smart Assist (PMA supplement)
Abion Inc
→
Apr 1, 2026
device pma
Abiomed, Inc. — Impella RP System (PMA supplement)
Abion Inc
→
Feb 18, 2026
device recall
Abiomed, Inc. device recall (Cls I)
Abion Inc
→
Feb 16, 2026
device recall
Abiomed, Inc. device recall (Cls I)
Abion Inc
→
Feb 6, 2026
device pma
Abiomed, Inc. — Impella RP System, Impella RP with Smart Assist System, Impella RP Flex System (PMA supplement)
Abion Inc
→
Feb 6, 2026
device pma
Abiomed, Inc. — Impella 2.5 System; Impella CP System; Impella CP with Smart Assist System; Impella 5.0 System, Impella 5.5 with Smart A (PMA supplement)
Abion Inc
→
Jan 27, 2026
device recall
Abiomed, Inc. device recall (Cls I)
Abion Inc
→
Jan 27, 2026
device recall
Abiomed, Inc. device recall (Cls I)
Abion Inc
→
Jan 27, 2026
device recall
Abiomed, Inc. device recall (Cls I)
Abion Inc
→
Dec 19, 2025
device pma
Abiomed, Inc. — Impella CP with SmartAssist; Impella 5.5 with SmartAssist (PMA supplement)
Abion Inc
→
Dec 19, 2025
device pma
Abiomed, Inc. — Impella CP with SmartAssist; Impella 5.5 with SmartAssist (PMA supplement)
Abion Inc
→
Dec 4, 2025
device recall
Abiomed, Inc. device recall (Cls II)
Abion Inc
→
Oct 8, 2025
device 510k
Abiomed, Inc. — 14Fr Low Profile Introducer Kit (510k cleared)
Abion Inc
→
Oct 1, 2025
device recall
Abiomed, Inc. device recall (Cls I)
Abion Inc
→
Oct 1, 2025
device pma
Abiomed, Inc. — Impella 5.5 with SmartAssist (PMA supplement)
Abion Inc
→
Sep 24, 2025
device pma
Abiomed, Inc. — Impella CP with SmartAssist (PMA supplement)
Abion Inc
→
Sep 19, 2025
device pma
Abiomed, Inc. — Impella 2.5; Impella CP; Impella CP with SmartAssist; Impella 5.0; Impella 5.5 with SmartAssist; Impella LD (PMA supplement)
Abion Inc
→
Sep 19, 2025
device pma
Abiomed, Inc. — Impella RP, Impella RP with SmartAssist, Impella RP Flex with SmartAssist (PMA supplement)
Abion Inc
→
Sep 16, 2025
device recall
Abiomed, Inc. device recall (Cls I)
Abion Inc
→
Sep 15, 2025
device pma
Abiomed, Inc. — Impella 5.5 with SmartAssist, Impella CP with SmartAssist, Purge Cassette (PMA supplement)
Abion Inc
→
Sep 15, 2025
device pma
Abiomed, Inc. — Purge Cassette (PMA supplement)
Abion Inc
→
Aug 20, 2025
device recall
Abiomed, Inc. device recall (Cls I)
Abion Inc
→
Aug 8, 2025
device pma
Abiomed, Inc. — Impella CP with SmartAssist System (PMA supplement)
Abion Inc
→
Aug 1, 2025
device pma
Abiomed, Inc. — Impella RP System; Impella RP with SmartAssist System; Impella RP Flex with SmartAssist System; (PMA supplement)
Abion Inc
→
Aug 1, 2025
device pma
Abiomed, Inc. — Impella 5.5 with SmartAssist System; Impella CP with SmartAssist System; Impella 2.5; Impella 5.0; Impella LD; (PMA supplement)
Abion Inc
→
Jul 25, 2025
device pma
Abiomed, Inc. — Impella RP, Impella RP with SmartAssist, and Impella RP Flex with SmartAssist (PMA supplement)
Abion Inc
→
Jul 25, 2025
device pma
Abiomed, Inc. — Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist, and Impella LD (PMA supplement)
Abion Inc
→
Jun 23, 2025
device pma
Abiomed, Inc. — Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist, and Impella LD (PMA supplement)
Abion Inc
→
Jun 23, 2025
device pma
Abiomed, Inc. — Impella RP, Impella RP with SmartAssist, and Impella RP Flex with SmartAssist (PMA supplement)
Abion Inc
→
Jun 20, 2025
device pma
Abiomed, Inc. — IMPELLA CP with Smart Assist (PMA supplement)
Abion Inc
→