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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.
 
DeviceARCTIC MODEL FRONT CARDIAC CRYOABLATION SYSTEM
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 NumberS029
Date Received06/04/2013
Decision Date08/07/2013
Product Code OAE 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL TO REPLACE THE OBSOLETE CENTRAL PROCESSING UNIT (CPU) OF THE CRYOCONSOLE WITH AN EQUIVALENT BOARD AND A FERRITE ADDITION TO THE FOOT PEDAL CONNECTOR.
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