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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceATS OPEN PIVOT BILEAFLET
Classification Nameheart-valve, mechanical
Generic Nameheart-valve, mechanical
Applicant
MEDTRONIC ATS MEDICAL, INC.
3905 annapolis lane, suite 105
plymouth, MN 55447
PMA NumberP990046
Supplement NumberS006
Date Received05/01/2002
Decision Date05/29/2002
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason express gmp supplement
Expedited Review Granted? No
Combination Product No
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.
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