PMA P140003S112
- Device
- Impella CP with SmartAssist
- Applicant
- Abiomed, Inc.
- PMA number
- P140003
- Supplement
- S112
- Product code
- OZD
- Decision date
- 2023-06-27
- Classification
- Cardiovascular
- Generic name
- Temporary non-roller type left heart support blood pump
- Approval order statement
- Approval for changes to the design of the catheter fixation mechanisms on the Impella CP with SmartAssist repositioning unit assembly.
Current openFDA PMA Record#
- Device
- Impella CP with SmartAssist
- Applicant
- Abiomed, Inc.
- PMA number
- P140003
- Supplement
- S112
- Product code
- OZD
- Generic name
- Temporary non-roller type left heart support blood pump
- Decision date
- 2023-06-27
- Decision code
- APPR
- Date received
- 2023-03-31
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for changes to the design of the catheter fixation mechanisms on the Impella CP with SmartAssist repositioning unit assembly.