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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 DUAL 8 CATHETER (NON-IRRIGATED), THERAPY 8MM THERMISTOR ABLATION CATHERER (NON-IRRIGATED) SAFIRE TX CATHETER (NO
Classification Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Generic Nameelectrophysiology ablation catheter
ApplicantST. JUDE MEDICAL
PMA NumberP040042
Supplement NumberS027
Date Received03/03/2014
Decision Date04/28/2014
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 changes to thermal and egm boards, upgrade to the firmware and software, addition of remote control fiber cord lengths and updates to the instruction for use of the ampere generator.
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