PMA P170011S036
- Device
- Impella RP and Impella RP with SmartAssist
- Applicant
- Abiomed, Inc.
- PMA number
- P170011
- Supplement
- S036
- Product code
- PYX
- Decision date
- 2022-03-16
- Generic name
- Temporary non-roller type right heart support blood pump
- Approval order statement
- Approval for an alternative luer to be used in the manufacture of the purge sidearm assembly.
Current openFDA PMA Record#
- Device
- Impella RP and Impella RP with SmartAssist
- Applicant
- Abiomed, Inc.
- PMA number
- P170011
- Supplement
- S036
- Product code
- PYX
- Generic name
- Temporary non-roller type right heart support blood pump
- Decision date
- 2022-03-16
- Decision code
- APPR
- Date received
- 2021-12-17
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for an alternative luer to be used in the manufacture of the purge sidearm assembly.