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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 NumberS028
Date Received06/28/2012
Decision Date02/13/2013
Product Code LWQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR A MODIFIED AORTIC SEWING CUFF AS AN EXTENSION TO THE LINE OF AVAILABLE VALVES; THE REQUEST APPLIED TO THE AORTIC SIZES OF 19, 21, 23, 25, AND 27/29 MM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ON-X AORTIC PROSTHETIC HEART VALVE WITH ANATOMIC SEWING RING, AND WILL BE GIVEN THE MODEL DESIGNATIONS OF ONXAN (STANDARD VALVE HOLDER) AND ONXANE (EXTENDED VALVE HOLDER).
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