PMA P170011S057

Device: Impella RP, Impella RP with SmartAssist, and Impella RP Flex with SmartAssist
Applicant: Abiomed, Inc.
PMA number: P170011
Supplement: S057
Product code: PYX
Decision date: 2025-06-23
Classification: Cardiovascular
Generic name: Temporary non-roller type right heart support blood pump
Approval order statement: approval for a change to the Automated Impella Controller (AIC) battery pack cells and gas gauge integrated circuit

Current openFDA PMA Record#

Device: Impella RP, Impella RP with SmartAssist, and Impella RP Flex with SmartAssist
Applicant: Abiomed, Inc.
PMA number: P170011
Supplement: S057
Product code: PYX
Generic name: Temporary non-roller type right heart support blood pump
Decision date: 2025-06-23
Decision code: APPR
Date received: 2025-03-27
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: approval for a change to the Automated Impella Controller (AIC) battery pack cells and gas gauge integrated circuit