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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/FREEZOR XTRA/FREEZOR MAX SURGICAL CARDIAC CRYOABLATION CATHETER/CCT.2 CRYOCONSOLE SYSTEM
Generic NameCardiac ablation percutaneous catheter
ApplicantMedtronic CryoCath LP
8200 CORAL SEA STREET
MOUNDS VIEW, MN 55112
PMA NumberP020045
Supplement NumberS026
Date Received03/09/2009
Decision Date07/07/2009
Product Code LPB 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR A NEW CRYOABLATION CONSOLE WHICH INCLUDES CHANGES TO THE HARDWARE, SOFTWARE, USER INTERFACE, AND MECHANICAL CIRCUIT FOR THE 7F FREEZOR CARDIAC CRYOABLATION CATHETER AND CRYOCONSOLE, 7F FREEZOR XTRA SURGICAL CATHETER AND CRYOCONSOLE, AND 9F FREEZOR MAX SURGICAL CATHETER AND CRYOCONSOLE. THE NEW CRYOABLATION CONSOLE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CRYOCONSOLE TO BE USED WITH THE AFOREMENTIONED CATHETERS.
Post-Approval StudyShow Report Schedule and Study Progress
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