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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.
 
DeviceCCT.2 CRYOABLATION CONSOLE SYSTEM
Generic NameCardiac ablation percutaneous catheter
ApplicantMedtronic Cryocath, LP
8200 Coral Sea St.
Mounds View, MN 55112
PMA NumberP020045
Supplement NumberS014
Date Received12/20/2005
Decision Date04/06/2006
Product Code LPB 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF THE FOOTSWITCH, ADDITIONAL EP CONNECTIVITY, ADDITIONAL EFFICIENCY IN VERIFICATION AND VALIDATION REPORTING, AND THE OTHER MINOR CHANGES LISTED ON PAGE 2 OF THE SUBMISSION.
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