PMA P170011S046
- Device
- Impella RP and Impella RP with SmartAssist
- Applicant
- Abiomed, Inc.
- PMA number
- P170011
- Supplement
- S046
- Product code
- PYX
- Decision date
- 2022-10-11
- Generic name
- Temporary non-roller type right heart support blood pump
- Approval order statement
- Modification to the process used to construct the retainer within the hybrid bearing of the motor.
Current openFDA PMA Record#
- Device
- Impella RP and Impella RP with SmartAssist
- Applicant
- Abiomed, Inc.
- PMA number
- P170011
- Supplement
- S046
- Product code
- PYX
- Generic name
- Temporary non-roller type right heart support blood pump
- Decision date
- 2022-10-11
- Decision code
- OK30
- Date received
- 2022-09-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modification to the process used to construct the retainer within the hybrid bearing of the motor.