Masters Series Mechanical Heart Valve, Regent Mechanical Heart Valve, Masters Series Aortic Valved Graft with Hemashield

FDA premarket approval P810002/S124 · decided 2025-02-20

Approval details

PMA number

P810002

Supplement

S124

Supplement type

Real-Time Process

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

Masters Series Mechanical Heart Valve, Regent Mechanical Heart Valve, Masters Series Aortic Valved Graft with Hemashield

Generic name

HEART-VALVE, MECHANICAL

Applicant

ABBOTT MEDICAL

Date received

2024-11-22

Decision date

2025-02-20

Days to decision

90 days

Decision code

APPR

Product code

LWQ

Advisory committee

Cardiovascular

Expedited review

No

Location

St. Paul, MN

Statement

approval for minor updates to the Masters Series Mechanical Heart Valve, Regent Mechanical Heart Valve, and Masters Series Aortic Valved Graft with Hemashield Graft Technology labeling to align with ISO 5840-2:2021 recommendations

510(k) clearances by this applicant