PMA P170011S048
- Device
- Impella RP Flex with SmartAssist
- Applicant
- Abiomed, Inc.
- PMA number
- P170011
- Supplement
- S048
- Product code
- PYX
- Decision date
- 2023-03-31
- Classification
- Cardiovascular
- Generic name
- Temporary non-roller type right heart support blood pump
- Approval order statement
- Approval for changes to the Instructions for Use to include femoral vein access for insertion of the Impella RP Flex.
Current openFDA PMA Record#
- Device
- Impella RP Flex with SmartAssist
- Applicant
- Abiomed, Inc.
- PMA number
- P170011
- Supplement
- S048
- Product code
- PYX
- Generic name
- Temporary non-roller type right heart support blood pump
- Decision date
- 2023-03-31
- Decision code
- APPR
- Date received
- 2023-01-04
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for changes to the Instructions for Use to include femoral vein access for insertion of the Impella RP Flex.