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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 ADVANCE CRYOBALLOON 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 NumberS042
Date Received08/05/2014
Decision Date08/27/2014
Product Code OAE 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
UPDATES TO THE QUALITY ASSURANCE FINAL INSPECTION (QA FINAL) AND FINAL HANDLE ASSEMBLY (P18) TO STREAMLINE THE MANUFACTURING FLOW, BALANCE THE WORKLOAD, AND REDUCE THE CYCLE TIME OF THE FINAL INSPECTION STEPS OF THE ARCTIC FRONT ADVANCE (AFA) CATHETERS.
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