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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.
 
DeviceFREEZOR CARDIAC CRYOABLATION CATHETERS, FREEZOR XTRA AND FREEZOR MAX SURGICAL CRYOABLATION DEVICES
Generic NameCardiac ablation percutaneous catheter
ApplicantMedtronic Cryocath, LP
8200 Coral Sea St.
Mounds View, MN 55112
PMA NumberP020045
Supplement NumberS042
Date Received02/23/2012
Decision Date04/12/2012
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 A MODIFICATION TO ALLOW THE USE OF THE ARCTIC FRONT ADVANCE BALLOON CATHETER (MODELS 2AF234 & 2AF284) WITH THE CRYOCONSOLE MODEL #106A3 AND IS INDICATED FOR USE IN PERFORMING CARDIAC ABLATION PROCEDURES.
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