PMA P170011S058

Device: Purge Cassette
Applicant: Abiomed, Inc.
PMA number: P170011
Supplement: S058
Product code: PYX
Decision date: 2025-09-15
Classification: Cardiovascular
Generic name: Temporary non-roller type right heart support blood pump
Approval order statement: approval for a manufacturing site located at STERIS Applied Sterilization Technologies, 435 Whitney Street, Northborough, MA 01532, which is limited to Ethylene Oxide sterilization of the Purge Cassette, Impella CP with SmartAssist, and Impella 5.5 with SmartAssist devices

Current openFDA PMA Record#

Device: Purge Cassette
Applicant: Abiomed, Inc.
PMA number: P170011
Supplement: S058
Product code: PYX
Generic name: Temporary non-roller type right heart support blood pump
Decision date: 2025-09-15
Decision code: APPR
Date received: 2025-05-15
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for a manufacturing site located at STERIS Applied Sterilization Technologies, 435 Whitney Street, Northborough, MA 01532, which is limited to Ethylene Oxide sterilization of the Purge Cassette, Impella CP with SmartAssist, and Impella 5.5 with SmartAssist devices