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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameFREEZOR CARDIAC CRYOABLATION CATHETERS, FREEZOR XTRA AND FREEZOR MAX SURGICAL CRYOABLATION DEVICES
Classification Namecardiac ablation percutaneous catheter
ApplicantMEDTRONIC CRYOCATH LP
PMA NumberP020045
Supplement NumberS042
Date Received02/24/2012
Decision Date04/12/2012
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a modification to allow the use of the arctic front advance balloon catheter (models 2af234 & 2af284) with the cryoconsole model #106a3 and is indicated for use in performing cardiac ablation procedures.
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