PMA P140003S122
- Device
- Impella CP with SmartAssist
- Applicant
- Abiomed, Inc.
- PMA number
- P140003
- Supplement
- S122
- Product code
- OZD
- Decision date
- 2025-02-04
- Classification
- Cardiovascular
- Generic name
- Temporary non-roller type left heart support blood pump
- Approval order statement
- approval for changes in the design of the Sheath Anchor sub-component of the Integrated Sheath Lock.
Current openFDA PMA Record#
- Device
- Impella CP with SmartAssist
- Applicant
- Abiomed, Inc.
- PMA number
- P140003
- Supplement
- S122
- Product code
- OZD
- Generic name
- Temporary non-roller type left heart support blood pump
- Decision date
- 2025-02-04
- Decision code
- APPR
- Date received
- 2024-10-30
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for changes in the design of the Sheath Anchor sub-component of the Integrated Sheath Lock.