PMA P170011S063

Device: Impella RP System
Applicant: Abiomed, Inc.
PMA number: P170011
Supplement: S063
Product code: PYX
Decision date: 2026-04-01
Classification: Cardiovascular
Generic name: Temporary non-roller type right heart support blood pump
Approval order statement: Modifications to the Impella RP with SmartAssist and Impella RP Flex with SmartAssist Instructions for Use (IFU) to include the addition of a caution statement and additional IFU language describing the potential risk of inaccurate differential pressure sensor readings.

Current openFDA PMA Record#

Device: Impella RP System
Applicant: Abiomed, Inc.
PMA number: P170011
Supplement: S063
Product code: PYX
Generic name: Temporary non-roller type right heart support blood pump
Decision date: 2026-04-01
Decision code: APPR
Date received: 2026-03-02
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Modifications to the Impella RP with SmartAssist and Impella RP Flex with SmartAssist Instructions for Use (IFU) to include the addition of a caution statement and additional IFU language describing the potential risk of inaccurate differential pressure sensor readings.