PMA P170038S028
- Device
- CentriMag Circulatory Support System
- Applicant
- Abbott
- PMA number
- P170038
- Supplement
- S028
- Product code
- DSQ
- Decision date
- 2026-02-18
- Classification
- Cardiovascular
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- alternative manufacturing workflow for CentriMag Blood Pump with receiving inspection and final packaging at Abbott facilities
Current openFDA PMA Record#
- Device
- CentriMag Circulatory Support System
- Applicant
- Abbott
- PMA number
- P170038
- Supplement
- S028
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2026-02-18
- Decision code
- OK30
- Date received
- 2026-01-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- alternative manufacturing workflow for CentriMag Blood Pump with receiving inspection and final packaging at Abbott facilities