Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | ST. JUDE MEDICAL MECHANICAL HEART VALVE SJM MASTERS SERIES WITH SILZONE |
Generic Name | HEART-VALVE, MECHANICAL |
Applicant | Abbott Medical 177 County Road B. East St. Paul, MN 55117 |
PMA Number | P810002 |
Supplement Number | S046 |
Date Received | 05/15/1997 |
Decision Date | 03/24/1998 |
Product Code |
LWQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order 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, 19, 21, 23, 25, and 27 mm). |
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