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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 NumberS026
Date Received11/01/1995
Decision Date12/07/1995
Withdrawal Date12/23/2011
Product Code LWQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR 100% ETO STERILIZATION
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