PMA P170011S044
- Device
- Impella RP, Impella RP with SmartAssist
- Applicant
- Abiomed, Inc.
- Product code
- PYX
- Decision date
- 2022-10-06
- Generic name
- Temporary non-roller type right heart support blood pump
- Approval order statement
- Approval for modifying the material used to construct the current retainer within the hybrid bearing of the motor.
Current openFDA PMA Record#
- Device
- Impella RP, Impella RP with SmartAssist
- Applicant
- Abiomed, Inc.
- PMA number
- P170011
- Supplement
- S044
- Product code
- PYX
- Generic name
- Temporary non-roller type right heart support blood pump
- Decision date
- 2022-10-06
- Decision code
- APPR
- Date received
- 2022-08-04
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for modifying the material used to construct the current retainer within the hybrid bearing of the motor.