PMA P170011S049
- Device
- Impella RP, Impella RP with Smart Assist, Impella $.0/LD
- Applicant
- Abiomed, Inc.
- PMA number
- P170011
- Supplement
- S049
- Product code
- PYX
- Decision date
- 2023-04-27
- Classification
- Cardiovascular
- Generic name
- Temporary non-roller type right heart support blood pump
- Approval order statement
- Approval of the revised protocol for the Impella Real-World Surveillance of patients using Sodium Bicarbonate.
Current openFDA PMA Record#
- Device
- Impella RP, Impella RP with Smart Assist, Impella $.0/LD
- Applicant
- Abiomed, Inc.
- PMA number
- P170011
- Supplement
- S049
- Product code
- PYX
- Generic name
- Temporary non-roller type right heart support blood pump
- Decision date
- 2023-04-27
- Decision code
- APPR
- Date received
- 2023-03-28
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the revised protocol for the Impella Real-World Surveillance of patients using Sodium Bicarbonate.