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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 ABLATION CATHETER & IBI-1500T9 RF ABLATION GENERATOR
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
ApplicantIrvine Biomedical, Inc.
2375 Morse Ave.
Irvine, CA 92614
PMA NumberP060019
Supplement NumberS005
Date Received07/14/2008
Decision Date06/12/2009
Product Code OAD 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR USE OF THE COOL POINT PUMP AND TUBING SET TO PROVIDE IRRIGATION OF THE THERAPY COOL PATH ABLATION CATHETER AS WELL AS MODIFICATION TO THE IBI 1500T9 RF ABLATION GENERATOR TO FUNCTION WITH THE COOL POINT PUMP. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME IBI-1500T9-CP RF ABLATION GENERATOR.
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