PMA P140003S020
- Device
- Impella Ventricular Support System
- Applicant
- Abiomed, Inc.
- PMA number
- P140003
- Supplement
- S020
- Product code
- OZD
- Decision date
- 2017-11-01
- Classification
- Temporary Non-roller Type Left Heart Support Blood Pump
- Generic name
- Temporary non-roller type left heart support blood pump
- Approval order statement
- Approval for a new environmentally controlled area at the current manufacturing facility
Current openFDA PMA Record#
- Device
- Impella Ventricular Support System
- Applicant
- Abiomed, Inc.
- PMA number
- P140003
- Supplement
- S020
- Product code
- OZD
- Generic name
- Temporary non-roller type left heart support blood pump
- Decision date
- 2017-11-01
- Decision code
- APPR
- Date received
- 2017-06-06
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a new environmentally controlled area at the current manufacturing facility