PMA P170038S008
- Device
- CentriMag Circulatory Support System
- Applicant
- Abbott
- PMA number
- P170038
- Supplement
- S008
- Product code
- DSQ
- Decision date
- 2021-10-22
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Approval for the transfer of injection molding equipment and processes for the pump components to a new facility location
Current openFDA PMA Record#
- Device
- CentriMag Circulatory Support System
- Applicant
- Abbott
- PMA number
- P170038
- Supplement
- S008
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2021-10-22
- Decision code
- APPR
- Date received
- 2021-08-24
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the transfer of injection molding equipment and processes for the pump components to a new facility location