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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.
 
DeviceCRYOCONSOLE
Generic NameCatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
ApplicantMedtronic CryoCath LP
8200 CORAL SEA STREET
MS MVS46
MOUNDS VIEW, MN 55112
PMA NumberP100010
Supplement NumberS048
Date Received03/16/2015
Decision Date04/03/2015
Product Code OAE 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR INSTALLATION OF FOUR NEW CATHETER RECOGNITION FILES, AS WELL AS LABELING CHANGES TO THE CRYOCONSOLE OPERATORS MANUAL.
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