PMA P810002S121

Device: Masters Series, Masters Series HP, Regent, Masters Series Aortic Valved Graft with Hemashield graft technology
Applicant: ABBOTT MEDICAL
PMA number: P810002
Supplement: S121
Product code: LWQ
Decision date: 2024-04-03
Classification: Cardiovascular
Generic name: HEART-VALVE, MECHANICAL
Approval order statement: for implementing rebranding of the SJM Masters Series Mechanical Heart Valve, SJM Regent Mechanical Heart Valve, and SJM Masters Valved Graft with Hemashield graft technology.

Current openFDA PMA Record#

Device: Masters Series, Masters Series HP, Regent, Masters Series Aortic Valved Graft with Hemashield graft technology
Applicant: ABBOTT MEDICAL
PMA number: P810002
Supplement: S121
Product code: LWQ
Generic name: HEART-VALVE, MECHANICAL
Decision date: 2024-04-03
Decision code: APPR
Date received: 2024-01-23
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: for implementing rebranding of the SJM Masters Series Mechanical Heart Valve, SJM Regent Mechanical Heart Valve, and SJM Masters Valved Graft with Hemashield graft technology.