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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 NumberS022
Date Received07/10/2012
Decision Date09/07/2012
Product Code
OAD[ Registered Establishments with OAD ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a design modification to the bond between that catheter shaft and the extension tubing. Specifically, you propose to change the adhesive from loctite to urethane and to modify the contact hole from a circular to an octagonal shape.
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