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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceON-X PROSTHETIC HEART VALVE
Generic NameHEART-VALVE, MECHANICAL
ApplicantOn-X Life Technologies, Inc.
1655 ROBERTS BLVD NW
KENNESAW, GA 30144
PMA NumberP000037
Supplement NumberS004
Date Received04/04/2005
Decision Date05/04/2005
Product Code LWQ 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGE IN THE MANUFACTURING PROCESS TO INCLUDE AN ADDITIONAL STANDARD LEAFLET INSPECTION STEP FOR REWORKED PRODUCT WITH UNACCEPTABLY HIGH LEAK TEST RESULT.
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