PMA P140003S119
- Device
- Impella 5.5 with SmartAssist
- Applicant
- Abiomed, Inc.
- PMA number
- P140003
- Supplement
- S119
- Product code
- OZD
- Decision date
- 2024-10-21
- Classification
- Cardiovascular
- Generic name
- Temporary non-roller type left heart support blood pump
- Approval order statement
- for a second supplier of the integrated patient cable of the Impella 5.5 with SmartAssist
Current openFDA PMA Record#
- Device
- Impella 5.5 with SmartAssist
- Applicant
- Abiomed, Inc.
- PMA number
- P140003
- Supplement
- S119
- Product code
- OZD
- Generic name
- Temporary non-roller type left heart support blood pump
- Decision date
- 2024-10-21
- Decision code
- OK30
- Date received
- 2024-09-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- for a second supplier of the integrated patient cable of the Impella 5.5 with SmartAssist