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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.
 
DeviceBALLOON CATHETER
Classification Namecatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Applicant
Medtronic CryoCath LP
8200 coral sea street
ms mvs46
mounds view, MN 55112
PMA NumberP100010
Supplement NumberS038
Date Received06/23/2014
Decision Date07/09/2014
Product Code
OAE[ Registered Establishments with OAE ]
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 
Addition of an inspection procedure for the low pressure regulator during manufacturing, as well as the replacement of an analog pressure gauge used during installation and maintenance with a digital one.
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