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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 AND FREEZOR XTRA SURGICAL CRYOABLATION CATHETERS & CCT.2 CRYOCONSOLE SYSTEM
Classification Namecardiac ablation percutaneous catheter
Generic Namecardiac ablation percutaneous catheter
Applicant
Medtronic CryoCath LP
8200 coral sea street
mounds view, MN 55112
PMA NumberP020045
Supplement NumberS017
Date Received03/14/2006
Decision Date04/12/2006
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
CHANGE TO THE INTERNAL QUALITY CONTROL AND INSPECTION PROCESS.
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