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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(R) HALL PROSTHETIC HEART VALVE AND VALVED CONDUITS
Generic NameHEART-VALVE, MECHANICAL
ApplicantMedtronic Cardiac Surgery
8299 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP790018
Supplement NumberS024
Date Received01/18/1995
Decision Date05/13/1996
Withdrawal Date12/23/2011
Product Code LWQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE USE OF OCCLUDERS MADE BY MEDTRONIC CARBON IMPLANTS (MCI) OF AUSTIN, TEXAS, AS A COMPONENT OF THE MEDTRONIC HALL PROSTHETIC HEART VALVE AND VALVED CONUITS, MODELS A7700, M7700, C7700, AND Z7700
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