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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
Generic NameHEART-VALVE, MECHANICAL
ApplicantMedtronic Cardiac Surgery
8299 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP790018
Supplement NumberS030
Date Received03/13/1997
Decision Date09/29/1997
Withdrawal Date12/23/2011
Product Code LWQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the Rotatable Aortic Valved Collagen Impregnated Conduit (Rotatable AVCIC, Model R7700).
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