PMA P170011S029
- Device
- Impella RP System
- Applicant
- Abiomed, Inc.
- PMA number
- P170011
- Supplement
- S029
- Product code
- PYX
- Decision date
- 2021-06-15
- Generic name
- Temporary non-roller type right heart support blood pump
- Approval order statement
- Approval for various labeling updates to add the results of the pediatric post-approval study.
Current openFDA PMA Record#
- Device
- Impella RP System
- Applicant
- Abiomed, Inc.
- PMA number
- P170011
- Supplement
- S029
- Product code
- PYX
- Generic name
- Temporary non-roller type right heart support blood pump
- Decision date
- 2021-06-15
- Decision code
- APPR
- Date received
- 2020-12-15
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for various labeling updates to add the results of the pediatric post-approval study.