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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.
 
DeviceATS OPEN PIVOT BILEAFLET
Generic NameHEART-VALVE, MECHANICAL
ApplicantMEDTRONIC ATS MEDICAL, INC.
3800 ANNAPOLIS LANE, SUITE 175
PLYMOUTH, MN 55447
PMA NumberP990046
Supplement NumberS006
Date Received05/01/2002
Decision Date05/29/2002
Product Code LWQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Express GMP Supplement
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL TO TRANSFER THE MANUFACTURING OF THE PYROLYTIC CARBON COATED HEART VALVE COMPONENTS FROM SULZER CARBOMEDICS, INC., TO ATS MEDICAL INC., MINNEAPOLIS, MINNESOTA.
Post-Approval StudyShow Report Schedule and Study Progress
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