- Device
- Impella 2.5, CP, and CP with SmartAssist
- Applicant
- Abiomed, Inc.
- PMA number
- P140003
- Supplement
- S065
- Product code
- OZD
- Generic name
- Temporary non-roller type left heart support blood pump
- Decision date
- 2020-06-26
- Decision code
- APPR
- Date received
- 2019-12-16
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for adding Dexter Magnetic Technologies as a supplier for the motor magnet component for the Impella 2.5, Impella CP, and Impella CP with SmartAssist.