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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 NameMECHANICAL HEART VALVE SJM(R) MASTER SERIES
Classification Nameheart-valve, mechanical
Generic Namemechanical heart valve
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP810002
Supplement NumberS041
Date Received03/07/1996
Decision Date09/04/1996
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason process change: packaging
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a new sterile package system for all of the st. Jude medical mechanical heart valve models, as described in attachment 1 of your submission.
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