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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.
 
DeviceCRYOABLATION CONSOLE
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 NumberS044
Date Received06/26/2012
Decision Date08/24/2012
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes related to updating for compliance to iec60601-1 3rd edition standards, removal of the floppy disk drive, and related labeling updates.
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