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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 FRONT CRYOABLATION CATHETER; ARCTIC FRONT ADVANCE CRYOABLATION CATHETER
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 NumberS035
Date Received03/05/2014
Decision Date04/03/2014
Product Code OAE 
Advisory Committee Cardiovascular
Clinical TrialsNCT00523978
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
UPDATES TO THE MANUFACTURING STEPS AND FIXTURES AT MANUFACTURING STATION P09 Y BLOCK TO SHAFT ASSEMBLY USED IN THE MANUFACTURE OF THE ARCTIC FRONT AND ARCTIC FRONTADVANCE CATHETERS.
Post-Approval StudyShow Report Schedule and Study Progress
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