PMA P140003S137

Device: Impella 5.5 with Smart Assist
Applicant: Abiomed, Inc.
PMA number: P140003
Supplement: S137
Product code: OZD
Decision date: 2026-04-07
Classification: Cardiovascular
Generic name: Temporary non-roller type left heart support blood pump
Approval order statement: the adoption of an additional sterilization site for the Impella 5.5 with SmartAssist S2 configuration into the site's current routine sterilization process established for other Impella products

Current openFDA PMA Record#

Device: Impella 5.5 with Smart Assist
Applicant: Abiomed, Inc.
PMA number: P140003
Supplement: S137
Product code: OZD
Generic name: Temporary non-roller type left heart support blood pump
Decision date: 2026-04-07
Decision code: OK30
Date received: 2026-03-09
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: the adoption of an additional sterilization site for the Impella 5.5 with SmartAssist S2 configuration into the site's current routine sterilization process established for other Impella products