PMA P170011S061

Device: Impella RP System, Impella RP with Smart Assist System, Impella RP Flex System
Applicant: Abiomed, Inc.
PMA number: P170011
Supplement: S061
Product code: PYX
Decision date: 2026-02-06
Classification: Cardiovascular
Generic name: Temporary non-roller type right heart support blood pump
Approval order statement: approval for a modification to the Instructions for Use to allow sodium bicarbonate to be used in the purge fluid for the Impella catheters if heparin should not be used per the physician’s clinical judgement.

Current openFDA PMA Record#

Device: Impella RP System, Impella RP with Smart Assist System, Impella RP Flex System
Applicant: Abiomed, Inc.
PMA number: P170011
Supplement: S061
Product code: PYX
Generic name: Temporary non-roller type right heart support blood pump
Decision date: 2026-02-06
Decision code: APPR
Date received: 2025-10-23
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: approval for a modification to the Instructions for Use to allow sodium bicarbonate to be used in the purge fluid for the Impella catheters if heparin should not be used per the physician’s clinical judgement.