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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 & FREEZOR MAX SURGICAL CRYOABLATION DEVICES & CRYOCONSOLE SYSTEM
Classification Namecardiac ablation percutaneous catheter
ApplicantCRYOCATH TECHNOLOGIES, INC.
PMA NumberP020045
Supplement NumberS029
Date Received03/15/2010
Decision Date10/29/2010
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at medtronic cryocath lp in point claire, quebec for warehousing and performing incoming inspections.
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