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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameST. JUDE MEDICAL MECHANICAL HEART VALVE SJM MASTERS SERIES WITH SILZONE
Classification Nameheart-valve, mechanical
Generic Namemechanical heart valve
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP810002
Supplement NumberS046
Date Received05/15/1997
Decision Date03/24/1998
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
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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