PMA P170038S031
- Device
- CentriMag™ Circulatory Support System
- Applicant
- Abbott
- PMA number
- P170038
- Supplement
- S031
- Product code
- DSQ
- Decision date
- 2026-05-05
- Classification
- Cardiovascular
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- A manufacturing change to implement a new Printed Circuit Board Assembly (PCBA) Test System for the Mag Monitor.
Current openFDA PMA Record#
- Device
- CentriMag™ Circulatory Support System
- Applicant
- Abbott
- PMA number
- P170038
- Supplement
- S031
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2026-05-05
- Decision code
- OK30
- Date received
- 2026-04-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- A manufacturing change to implement a new Printed Circuit Board Assembly (PCBA) Test System for the Mag Monitor.