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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 NumberS002
Date Received05/31/2007
Decision Date07/17/2007
Product Code OAD 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A CHANGE FROM A SHAFT CONTAINING A PROXIMAL BRAIDED SECTION AND DISTAL NON-BRAIDED SECTION BRAIDED TUBING FOR BOTH PROXIMAL AND DISTAL SECTIONS.
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