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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 ABLATION CATHETER AND THERAPY COOL FLEX ABLATION CATHETER
Classification Namecardiac ablation percutaneous catheter
ApplicantST. JUDE MEDICAL
PMA NumberP110016
Supplement NumberS017
Date Received04/20/2015
Decision Date05/20/2015
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in manufacturing room location of the band electrode sub-assembly.
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