PMA P140003S082
- Device
- Impella Left Ventricular Support Systems
- Applicant
- Abiomed, Inc.
- PMA number
- P140003
- Supplement
- S082
- Product code
- OZD
- Decision date
- 2021-07-13
- Generic name
- Temporary non-roller type left heart support blood pump
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- Impella Left Ventricular Support Systems
- Applicant
- Abiomed, Inc.
- PMA number
- P140003
- Supplement
- S082
- Product code
- OZD
- Generic name
- Temporary non-roller type left heart support blood pump
- Decision date
- 2021-07-13
- Decision code
- APPR
- Date received
- 2021-05-03
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.