PMA P140003
- Device
- Impella CP with SmartAssist
- Applicant
- Abiomed, Inc.
- PMA number
- P140003
- Supplement
- S106
- Product code
- OZD
- Decision date
- 2026-06-15
- Generic name
- Temporary non-roller type left heart support blood pump
- Approval order statement
- Approval for additional pass/fail criteria during final qualification to detect an irregular purge gap in the sleeve bearing.
Current openFDA PMA Record#
- Device
- Impella CP with SmartAssist
- Applicant
- Abiomed, Inc.
- PMA number
- P140003
- Supplement
- S138
- Product code
- OZD
- Generic name
- Temporary non-roller type left heart support blood pump
- Decision date
- 2026-06-15
- Decision code
- APPR
- Date received
- 2026-05-18
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for additional pass/fail criteria during final qualification to detect an irregular purge gap in the sleeve bearing.