PMA P140003S038
- Device
- Impella 2.5, Impella CP, Impella 5.0 and Impella LD
- Applicant
- Abiomed, Inc.
- PMA number
- P140003
- Supplement
- S038
- Product code
- OZD
- Decision date
- 2018-08-28
- Classification
- Temporary Non-roller Type Left Heart Support Blood Pump
- Generic name
- Temporary non-roller type left heart support blood pump
- Approval order statement
- changes to the manufacturing of Impella 2.5, CP, 5.0, and LD.
Current openFDA PMA Record#
- Device
- Impella 2.5, Impella CP, Impella 5.0 and Impella LD
- Applicant
- Abiomed, Inc.
- PMA number
- P140003
- Supplement
- S038
- Product code
- OZD
- Generic name
- Temporary non-roller type left heart support blood pump
- Decision date
- 2018-08-28
- Decision code
- OK30
- Date received
- 2018-07-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- changes to the manufacturing of Impella 2.5, CP, 5.0, and LD.