- Device
- Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.5 with SmartAssist, and Impella 5.0/LD
- Applicant
- Abiomed, Inc.
- PMA number
- P140003
- Supplement
- S079
- Product code
- OZD
- Generic name
- Temporary non-roller type left heart support blood pump
- Decision date
- 2021-02-17
- Decision code
- OK30
- Date received
- 2021-01-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- New environmentally controlled manufacturing room for the Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist, and Impella LD.