PMA P140003S102
- Device
- Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD
- Applicant
- Abiomed, Inc.
- PMA number
- P140003
- Supplement
- S102
- Product code
- OZD
- Decision date
- 2022-08-18
- Generic name
- Temporary non-roller type left heart support blood pump
- Approval order statement
- Approval of the protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD
- Applicant
- Abiomed, Inc.
- PMA number
- P140003
- Supplement
- S102
- Product code
- OZD
- Generic name
- Temporary non-roller type left heart support blood pump
- Decision date
- 2022-08-18
- 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.