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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.
 
DeviceCRYOABLATION CONSOLE
Generic NameCardiac ablation percutaneous catheter
ApplicantMedtronic CryoCath LP
8200 CORAL SEA STREET
MOUNDS VIEW, MN 55112
PMA NumberP020045
Supplement NumberS046
Date Received02/15/2013
Decision Date03/06/2014
Product Code LPB 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE LOCATED AT PLEXUS CORPORATION, IN BUFFALO GROVE, ILLINOIS.
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