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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.
 
DeviceSAFIRE BLU IRRIGATED ABLATION CATHETER & THERAPY COOL PATH CATHETER
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
ApplicantIrvine Biomedical, Inc.
2375 Morse Ave.
Irvine, CA 92614
PMA NumberP060019
Supplement NumberS009
Date Received05/14/2009
Decision Date02/23/2011
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 TO ADD BI-DIRECTIONAL STEERING TO THE THERAPY COOL PATH ABLATION CATHETER. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES SAFIRE BLU IRRIGATED ABLATION CATHETER AND THERAPY COOL PATH ABLATION CATHETER.
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