PMA P140003S124

Device: Impella CP with SmartAssist System
Applicant: Abiomed, Inc.
PMA number: P140003
Supplement: S124
Product code: OZD
Decision date: 2025-08-08
Classification: Cardiovascular
Generic name: Temporary non-roller type left heart support blood pump
Approval order statement: Approval for a process update to 1) the manufacturing of the KR Pigtail at a second-tier supplier; and 2) sub-assembly processes performed at Abiomed.

Current openFDA PMA Record#

Device: Impella CP with SmartAssist System
Applicant: Abiomed, Inc.
PMA number: P140003
Supplement: S124
Product code: OZD
Generic name: Temporary non-roller type left heart support blood pump
Decision date: 2025-08-08
Decision code: APPR
Date received: 2025-02-14
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a process update to 1) the manufacturing of the KR Pigtail at a second-tier supplier; and 2) sub-assembly processes performed at Abiomed.