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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 ABLATION CATHETER
Classification Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
ApplicantST. JUDE MEDICAL
PMA NumberP060019
Supplement NumberS015
Date Received11/16/2010
Decision Date01/11/2011
Product Code
OAD[ Registered Establishments with OAD ]
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 for a design modification to the tip electrode stem outer diameter (od) so that the gap between the tip electrode od and tube inside diameter (id) is reduced to -0. 0015¿ to +0. 0015¿ from -0. 003¿ to +0. 003¿ for consistent gap interference.
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