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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.
 
DeviceMEDTRONIC HALL PROSTHETIC HEART VALVE
Generic NameHEART-VALVE, MECHANICAL
ApplicantMEDTRONIC CARDIAC SURGERY
8299 CENTRAL AVE., N.E.
SPRING LAKE PARK, MN 55432-3576
PMA NumberP790018
Supplement NumberS036
Date Received10/17/2000
Decision Date11/09/2000
Withdrawal Date 12/23/2011
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  
ALTERNATE SUPPLIER FOR THE POLYTETRAFLUOROETHYLENE (PTFE) FABRIC CONSTRUCTED OF PTFE YARN. THIS FABRIC IS USED TO MANUFACTURE THE SEWING RING COMPONENT FOR THE MEDTRONIC HALL PROSTHETIC HEART VALVE, MODEL A7700, SIZES 20, 22, AND 24 MM.
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