PMA P170011S064
- Device
- Impella RP Flex with SmartAssist
- Applicant
- Abiomed, Inc.
- PMA number
- P170011
- Supplement
- S064
- Product code
- PYX
- Decision date
- 2026-10-26
- Classification
- Cardiovascular
- Generic name
- Temporary non-roller type right heart support blood pump
- Approval order statement
- to add a supplier for the RP outflow cage
Current openFDA PMA Record#
- Device
- Impella RP Flex with SmartAssist
- Applicant
- Abiomed, Inc.
- PMA number
- P170011
- Supplement
- S064
- Product code
- PYX
- Generic name
- Temporary non-roller type right heart support blood pump
- Decision date
- 2026-10-26
- Decision code
- OK30
- Date received
- 2026-09-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to add a supplier for the RP outflow cage