PMA P170011S059
- Device
- Impella RP, Impella RP with SmartAssist, and Impella RP Flex with SmartAssist
- Applicant
- Abiomed, Inc.
- PMA number
- P170011
- Supplement
- S059
- Product code
- PYX
- Decision date
- 2025-07-25
- Classification
- Cardiovascular
- Generic name
- Temporary non-roller type right heart support blood pump
- Approval order statement
- a change to the component bonding process used for the pressure storage set assembly
Current openFDA PMA Record#
- Device
- Impella RP, Impella RP with SmartAssist, and Impella RP Flex with SmartAssist
- Applicant
- Abiomed, Inc.
- PMA number
- P170011
- Supplement
- S059
- Product code
- PYX
- Generic name
- Temporary non-roller type right heart support blood pump
- Decision date
- 2025-07-25
- Decision code
- OK30
- Date received
- 2025-06-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change to the component bonding process used for the pressure storage set assembly