PMA P140003S089
- Device
- Impella CP with SmartAssist System, Impella 5.5 with SmartAssist System
- Applicant
- Abiomed, Inc.
- PMA number
- P140003
- Supplement
- S089
- Product code
- OZD
- Decision date
- 2021-11-22
- Generic name
- Temporary non-roller type left heart support blood pump
- Approval order statement
- Approval for the design change to two strain relief subcomponents of the pump handle.
Current openFDA PMA Record#
- Device
- Impella CP with SmartAssist System, Impella 5.5 with SmartAssist System
- Applicant
- Abiomed, Inc.
- PMA number
- P140003
- Supplement
- S089
- Product code
- OZD
- Generic name
- Temporary non-roller type left heart support blood pump
- Decision date
- 2021-11-22
- Decision code
- APPR
- Date received
- 2021-09-15
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the design change to two strain relief subcomponents of the pump handle.