- Device
- Impella 2.5, Impella CP, Impelia CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist and Impella LD
- Applicant
- Abiomed, Inc.
- PMA number
- P140003
- Supplement
- S077
- Product code
- OZD
- Generic name
- Temporary non-roller type left heart support blood pump
- Decision date
- 2020-11-06
- Decision code
- OK30
- Date received
- 2020-10-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Automate a process during the end qualification test process for the Impella pumps.