- Device
- Impella 2.5; Impella CP; Impella CP with SmartAssist; Impella 5.0; Impella 5.5 with SmartAssist; Impella LD
- Applicant
- Abiomed, Inc.
- PMA number
- P140003
- Supplement
- S129
- Product code
- OZD
- Generic name
- Temporary non-roller type left heart support blood pump
- Decision date
- 2025-09-19
- Decision code
- OK30
- Date received
- 2025-08-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- addition of a third mounting screw for the Automated Impella Controller (AIC) purge assembly's purge disc retainer, implementation of a specification for the mounting screw torque during installation, and updates to the annual preventive maintenance procedure for the purge disc retainer