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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 NameON-X PROSTHETIC HEART VALVE
Classification Nameheart-valve, mechanical
Generic Namereplacement heart valve
ApplicantON-X TECHNOLOGIES, INC
PMA NumberP000037
Supplement NumberS016
Date Received07/01/2009
Decision Date10/16/2009
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to move a manufacturing operation from an outside vendor to in-house.
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