- Device
- Impella 5.5 with SmartAssist, Impella CP with SmartAssist, Purge Cassette
- Applicant
- Abiomed, Inc.
- PMA number
- P140003
- Supplement
- S126
- Product code
- OZD
- Generic name
- Temporary non-roller type left 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