PMA P170038S025
- Device
- CentriMag™ Circulatory Support System
- Applicant
- Abbott
- PMA number
- P170038
- Supplement
- S025
- Product code
- DSQ
- Decision date
- 2025-12-01
- Classification
- Cardiovascular
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- approval of changes to the CentriMag Circulatory Support System Clinical Reference Manual to include information on the CentriMag FTW Post-Approval Study
Current openFDA PMA Record#
- Device
- CentriMag™ Circulatory Support System
- Applicant
- Abbott
- PMA number
- P170038
- Supplement
- S025
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2025-12-01
- Decision code
- APPR
- Date received
- 2025-07-02
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- approval of changes to the CentriMag Circulatory Support System Clinical Reference Manual to include information on the CentriMag FTW Post-Approval Study