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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.
 
Device9F FREEZOR MAX SURGICAL CARDIAC CRYOABLATION DEVICE
Generic NameCardiac ablation percutaneous catheter
ApplicantMedtronic CryoCath LP
8200 CORAL SEA STREET
MOUNDS VIEW, MN 55112
PMA NumberP020045
Supplement NumberS006
Date Received05/10/2004
Decision Date10/26/2004
Product Code LPB 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE 9F FREEZOR MAX SURGICAL CARDIAC CRYOABLATION DEVICE, A MODIFICATION TO THE FREEZOR XTRA CARDIAC CRYOABLATION SYSTEM PREVIOUSLY APPROVED UNDER P020045/S005. THE DEVICE IS INDICATED FOR MINIMALLY INVASIVE CARDIAC SURGERY PROCEDURES, INCLUDING SURGICAL TREATMENT OF CARDIAC ARRHYTHMIAS.
Post-Approval StudyShow Report Schedule and Study Progress
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