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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 NameUNIDIRECTIONAL THERMOCOOL SF NAV CATHETER
Classification Namecatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
ApplicantBIOSENSE WEBSTER, INC.
PMA NumberP030031
Supplement NumberS045
Date Received08/13/2012
Decision Date10/02/2012
Product Code
OAE[ Registered Establishments with OAE ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for extending the shelf live for the catheter in the object of the current letter from one to three years.
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