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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,FREEZOR XTRA & FREEZOR MAX CRYOABLATION DEVICES
Generic NameCardiac ablation percutaneous catheter
ApplicantMedtronic Cryocath, LP
8200 Coral Sea St.
Mounds View, MN 55112
PMA NumberP020045
Supplement NumberS021
Date Received01/09/2007
Decision Date04/18/2007
Product Code LPB 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR CHANGES TO THE LEAK DETECTION SYSTEM IN THE FREEZOR CATHETER AND FREEZOR XTRA DEVICES FROM A SINGLE BARE STAINLESS STEEL WIRE TO A DUPLEX INSULATED WIRE MADE OF TWO ELECTRODES.
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