PMA P170011S055

Device: Impella RP with SmartAssist, Impella RP Flex with SmartAssist
Applicant: Abiomed, Inc.
PMA number: P170011
Supplement: S055
Product code: PYX
Decision date: 2025-01-10
Classification: Cardiovascular
Generic name: Temporary non-roller type right heart support blood pump
Approval order statement: approval for a labeling change to reinforce the risk of potential interaction between the tip of guidewires, indwelling central venous lines or devices and the inlet of the Impella pumps during the insertion, manipulation, and removal of those devices.

Current openFDA PMA Record#

Device: Impella RP with SmartAssist, Impella RP Flex with SmartAssist
Applicant: Abiomed, Inc.
PMA number: P170011
Supplement: S055
Product code: PYX
Generic name: Temporary non-roller type right heart support blood pump
Decision date: 2025-01-10
Decision code: APPR
Date received: 2024-12-19
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: approval for a labeling change to reinforce the risk of potential interaction between the tip of guidewires, indwelling central venous lines or devices and the inlet of the Impella pumps during the insertion, manipulation, and removal of those devices.