PMA P170011S043
- Device
- Impella RP, Impella RP with SmartAssist and RP Flex with SmartAssist
- Applicant
- Abiomed, Inc.
- Product code
- PYX
- Decision date
- 2022-08-19
- Generic name
- Temporary non-roller type right heart support blood pump
- Approval order statement
- Approval of the protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- Impella RP, Impella RP with SmartAssist and RP Flex with SmartAssist
- Applicant
- Abiomed, Inc.
- PMA number
- P170011
- Supplement
- S043
- Product code
- PYX
- Generic name
- Temporary non-roller type right heart support blood pump
- Decision date
- 2022-08-19
- Decision code
- APPR
- Date received
- 2022-07-20
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the protocol for the post-approval study (PAS) protocol.