PMA P140003S057
- Device
- Automated Impella Controller
- Applicant
- Abiomed, Inc.
- Product code
- OZD
- Decision date
- 2020-01-30
- Generic name
- Temporary non-roller type left heart support blood pump
- Approval order statement
- Approval for a design change for the Automated Impella Controller (AIC) carrier board.
Current openFDA PMA Record#
- Device
- Automated Impella Controller
- Applicant
- Abiomed, Inc.
- PMA number
- P140003
- Supplement
- S057
- Product code
- OZD
- Generic name
- Temporary non-roller type left heart support blood pump
- Decision date
- 2020-01-30
- Decision code
- APPR
- Date received
- 2019-08-30
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a design change for the Automated Impella Controller (AIC) carrier board.