PMA P170011S045
- Device
- Impella RP, Impella RP with SmartAssist
- Applicant
- Abiomed, Inc.
- PMA number
- P170011
- Supplement
- S045
- Product code
- PYX
- Decision date
- 2022-08-31
- Generic name
- Temporary non-roller type right heart support blood pump
- Approval order statement
- Change to the bonding process between the pressure reservoir and check valve components in the pressure storage set assembly.
Current openFDA PMA Record#
- Device
- Impella RP, Impella RP with SmartAssist
- Applicant
- Abiomed, Inc.
- PMA number
- P170011
- Supplement
- S045
- Product code
- PYX
- Generic name
- Temporary non-roller type right heart support blood pump
- Decision date
- 2022-08-31
- Decision code
- OK30
- Date received
- 2022-08-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the bonding process between the pressure reservoir and check valve components in the pressure storage set assembly.