PMA P170011S031
- Device
- Impella RP System
- Applicant
- Abiomed, Inc.
- PMA number
- P170011
- Supplement
- S031
- Product code
- PYX
- Decision date
- 2021-07-09
- Generic name
- Temporary non-roller type right heart support blood pump
- Approval order statement
- Approval for material and assembly design changes to the interior cylinder, rack and piston components of the Purge Cassette.
Current openFDA PMA Record#
- Device
- Impella RP System
- Applicant
- Abiomed, Inc.
- PMA number
- P170011
- Supplement
- S031
- Product code
- PYX
- Generic name
- Temporary non-roller type right heart support blood pump
- Decision date
- 2021-07-09
- Decision code
- APPR
- Date received
- 2020-12-31
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for material and assembly design changes to the interior cylinder, rack and piston components of the Purge Cassette.