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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.
Classification Nameheart-valve, mechanical
Generic Nameheart valve
PMA NumberP790018
Supplement NumberS027
Date Received03/05/1996
Decision Date08/19/1996
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the transfer of sewing ring fabrication and attachment, and sterile packaging manufacturing processes from your facility located at 7000 central ave. , minneapolis, mn to your facility at 18011 s. Mitchell, irvine, ca.