PMA P140003S063
- Device
- Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist and Impella LD
- Applicant
- Abiomed, Inc.
- PMA number
- P140003
- Supplement
- S063
- Product code
- OZD
- Decision date
- 2019-11-25
- Classification
- Temporary Non-roller Type Left Heart Support Blood Pump
- Generic name
- Temporary non-roller type left heart support blood pump
- Approval order statement
- Use an additional sterilization chamber at the current sterilization facility for the ethelene oxide sterilization of Impella products.
Current openFDA PMA Record#
- Device
- Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist and Impella LD
- Applicant
- Abiomed, Inc.
- PMA number
- P140003
- Supplement
- S063
- Product code
- OZD
- Generic name
- Temporary non-roller type left heart support blood pump
- Decision date
- 2019-11-25
- Decision code
- OK30
- Date received
- 2019-10-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Use an additional sterilization chamber at the current sterilization facility for the ethelene oxide sterilization of Impella products.