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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.
 
Device7F FREEZOR CARDIAC CYROABLATION CATHETER AND CCT.2 CRYOCONSOLE SYSTEM
Generic NameCardiac ablation percutaneous catheter
ApplicantMedtronic CryoCath LP
8200 CORAL SEA STREET
MOUNDS VIEW, MN 55112
PMA NumberP020045
Supplement NumberS001
Date Received06/05/2003
Decision Date04/13/2004
Product Code LPB 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL OF THE POST-APPROVAL STUDY FOR THE DEVICE.
Post-Approval StudyShow Report Schedule and Study Progress
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