PMA P140003S070
- Device
- Automated Impella Controller
- Applicant
- Abiomed, Inc.
- PMA number
- P140003
- Supplement
- S070
- Product code
- OZD
- Decision date
- 2020-04-17
- Generic name
- Temporary non-roller type left heart support blood pump
- Approval order statement
- Approval for software changes (v8.3).
Current openFDA PMA Record#
- Device
- Automated Impella Controller
- Applicant
- Abiomed, Inc.
- PMA number
- P140003
- Supplement
- S070
- Product code
- OZD
- Generic name
- Temporary non-roller type left heart support blood pump
- Decision date
- 2020-04-17
- Decision code
- APPR
- Date received
- 2020-02-13
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for software changes (v8.3).