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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
Classification Nameheart-valve, mechanical
Generic Namecoated aortic valved graft
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP810002
Supplement NumberS076
Date Received06/13/2011
Decision Date08/11/2011
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the specification range for the courses per inch (cpi) and thickness of the ptfe fabric used in the construction of the ptfe sewing cuff used with the masters series valves, as well as approval of two changes intended to offset the increase in the force required for valve rotation (torque) associated with the fabric modification. These proposed changes are for the increase in the diameter of the rotation spring and retainer id and reducing the lower limit of torque from 2. 0 in-oz to 0. 2 in-oz.
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