ST. JUDE MEDICAL MECHANICAL HEART VALVE SJM MASTERS SERIES WITH SILZONE

FDA premarket approval P810002/S046 · decided 1998-03-24

Approval details

PMA number

P810002

Supplement

S046

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

ST. JUDE MEDICAL MECHANICAL HEART VALVE SJM MASTERS SERIES WITH SILZONE

Generic name

HEART-VALVE, MECHANICAL

Applicant

ABBOTT MEDICAL

Date received

1997-05-15

Decision date

1998-03-24

Days to decision

313 days

Decision code

APPR

Product code

LWQ

Advisory committee

Cardiovascular

Expedited review

No

Location

St. Paul, MN

Statement

Approval for the addition of silver to the sewing cuff of the St. Jude Medical Mechanical Heart Valve SJM Masters Series. The device, as modified, will be marketed under the trade name St. Jude Medical Mechanical Heart Valve SJM Masters Series with Silzone Coating and will be available in the following model numbers and sizes: AS-601 and AECS-602 (19, 21, 23, 25, 27, 29, and 31 mm), MS-601 and MECS-602 (19, 21, 23, 25, 27, 29, 31, and 33 mm), and AHPS-605, MHPS-605, AEHPS-606, and MEHPS-606 (17,

510(k) clearances by this applicant