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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 CRYOABLATION CATHETER & 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 NumberS012
Date Received10/13/2005
Decision Date11/18/2005
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typespecial (immediate track)
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR CHANGES IN BOTH THE INCOMING AND FINAL QUALITY INSPECTIONS FROM THE CURRENT METHOD OF A RANDOM SAMPLING OF DEVICES TO EVALUATING 100% OF THE INCOMING SHAFTS COIL DIMENSIONS AND PERFORMING DEFLECTION TESTING ON 100% OF THE FINISHED SHAFTS.
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