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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 NameTHERAPY COOL PATH DUO AND SAFIRE BLU DUO ABLATION CATHETERS
Classification Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
ApplicantST. JUDE MEDICAL
PMA NumberP110016
Supplement NumberS009
Date Received08/30/2013
Decision Date09/27/2013
Product Code
OAD[ Registered Establishments with OAD ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Additional sterilization chamber for the therapy series ablation catheters.
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