PMA P140003S064
- Device
- Impella 5.5 with SmartAssist
- Applicant
- Abiomed, Inc.
- PMA number
- P140003
- Supplement
- S064
- Product code
- OZD
- Decision date
- 2019-11-28
- Classification
- Temporary Non-roller Type Left Heart Support Blood Pump
- Generic name
- Temporary non-roller type left heart support blood pump
- Approval order statement
- Add a second supplier for the stainless-steel Impella 5.5 Inflow Cage.
Current openFDA PMA Record#
- Device
- Impella 5.5 with SmartAssist
- Applicant
- Abiomed, Inc.
- PMA number
- P140003
- Supplement
- S064
- Product code
- OZD
- Generic name
- Temporary non-roller type left heart support blood pump
- Decision date
- 2019-11-28
- Decision code
- OK30
- Date received
- 2019-11-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add a second supplier for the stainless-steel Impella 5.5 Inflow Cage.