PMA P170038S033
- Device
- CentriMag™ Circulatory Support System
- Applicant
- Abbott
- PMA number
- P170038
- Supplement
- S033
- Product code
- DSQ
- Decision date
- 2026-10-02
- Classification
- Cardiovascular
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- an additional second-tier supplier of the CentriMag Motor Protection Cup component
Current openFDA PMA Record#
- Device
- CentriMag™ Circulatory Support System
- Applicant
- Abbott
- PMA number
- P170038
- Supplement
- S033
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2026-10-02
- Decision code
- OK30
- Date received
- 2026-09-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an additional second-tier supplier of the CentriMag Motor Protection Cup component