PMA P170038S023
- Device
- CentriMag Circulatory Support System
- Applicant
- Abbott
- PMA number
- P170038
- Supplement
- S023
- Product code
- DSQ
- Decision date
- 2025-09-29
- Classification
- Cardiovascular
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Approval for a design change to the AC/DC power supply of the CentriMag Console.
Current openFDA PMA Record#
- Device
- CentriMag Circulatory Support System
- Applicant
- Abbott
- PMA number
- P170038
- Supplement
- S023
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2025-09-29
- Decision code
- APPR
- Date received
- 2025-03-04
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a design change to the AC/DC power supply of the CentriMag Console.