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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 NameARCTIC MODEL FRONT CARDIAC CRYOABLATION SYSTEM
Classification Namecatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
ApplicantMEDTRONIC CRYOCATH LP
PMA NumberP100010
Supplement NumberS029
Date Received06/04/2013
Decision Date08/07/2013
Product Code
OAE[ Registered Establishments with OAE ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to replace the obsolete central processing unit (cpu) of the cryoconsole with an equivalent board and a ferrite addition to the foot pedal connector.
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