PMA P170011S030
- Device
- Impella RP with SmartAssist System
- Applicant
- Abiomed, Inc.
- PMA number
- P170011
- Supplement
- S030
- Product code
- PYX
- Decision date
- 2021-06-28
- Generic name
- Temporary non-roller type right heart support blood pump
- Approval order statement
- Approval for a design modification to the Impella RP System involving the addition of a fiber-optic pressure sensor.
Current openFDA PMA Record#
- Device
- Impella RP with SmartAssist System
- Applicant
- Abiomed, Inc.
- PMA number
- P170011
- Supplement
- S030
- Product code
- PYX
- Generic name
- Temporary non-roller type right heart support blood pump
- Decision date
- 2021-06-28
- Decision code
- APPR
- Date received
- 2020-12-30
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a design modification to the Impella RP System involving the addition of a fiber-optic pressure sensor.