PMA P170011S037

Device: Impella RP, Impella RP with SmartAssist
Applicant: Abiomed, Inc.
PMA number: P170011
Supplement: S037
Product code: PYX
Decision date: 2022-03-08
Generic name: Temporary non-roller type right heart support blood pump
Approval order statement: Replace a discontinued model of the electrical safety analyzer with a newer model for the final functional testing of the Automated Impella Controller.

Current openFDA PMA Record#

Device: Impella RP, Impella RP with SmartAssist
Applicant: Abiomed, Inc.
PMA number: P170011
Supplement: S037
Product code: PYX
Generic name: Temporary non-roller type right heart support blood pump
Decision date: 2022-03-08
Decision code: OK30
Date received: 2022-02-09
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Replace a discontinued model of the electrical safety analyzer with a newer model for the final functional testing of the Automated Impella Controller.