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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 NumberS037
Date Received07/03/1995
Decision Date08/11/1995
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the use of proof testing in the evaluation of st. Junde medical mechanical heart valves constructed with carbomedics, inc. Manufactured components.
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