- Device
- Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist and Impella LD
- Applicant
- Abiomed, Inc.
- PMA number
- P140003
- Supplement
- S071
- Product code
- OZD
- Generic name
- Temporary non-roller type left heart support blood pump
- Decision date
- 2020-04-09
- Decision code
- OK30
- Date received
- 2020-03-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementing a semi-automated test fixture for the leakage current measurement test performed during the final inspection for the Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist, Impella LD, and Impella RP catheters.