PMA P170011S021
- Device
- Impella RP System
- Applicant
- Abiomed, Inc.
- PMA number
- P170011
- Supplement
- S021
- Product code
- PYX
- Decision date
- 2020-04-01
- Generic name
- Temporary non-roller type right heart support blood pump
- Approval order statement
- Approval for a labeling change related to the use of the Automated Impella Controller (AIC) during air transport.
Current openFDA PMA Record#
- Device
- Impella RP System
- Applicant
- Abiomed, Inc.
- PMA number
- P170011
- Supplement
- S021
- Product code
- PYX
- Generic name
- Temporary non-roller type right heart support blood pump
- Decision date
- 2020-04-01
- Decision code
- APPR
- Date received
- 2020-01-28
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for a labeling change related to the use of the Automated Impella Controller (AIC) during air transport.