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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceTHERAPY COOL PATH CARDIAC ABLATION CATHETER AND 1500T9 CARDIAC ABLATION GENERATOR
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
ApplicantIrvine Biomedical, Inc.
2375 Morse Ave.
Irvine, CA 92614
PMA NumberP060019
Supplement NumberS003
Date Received06/07/2007
Decision Date07/26/2007
Product Code OAD 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A MINOR DESIGN CHANGE WHICH ADDED A VOLUME CONTROL TO THE AUDIBLE OUTPUT DEVICE TO PERMIT THE USER TO VARY THE VOLUME OF THE CONTINUOUS BEEPING SOUND MADE DURING RADIOFREQUENCY DELIVERY OF POWER.
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