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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 DUO/COOL PATH DUO ABLATION CATHETERS, VERISENSE ENABLED AND VERISENSE SYSTEM AND IBI 1500T9-CP V1.6 CARDIAC
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
ApplicantABBOTT MEDICAL
2375 Morse Ave.
Plymouth, MN 55442
PMA NumberP110016
Supplement NumberS007
Date Received03/07/2013
Decision Date08/29/2013
Product Code OAD 
Advisory Committee Cardiovascular
Clinical TrialsNCT01401361
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 THE SAFIRE DUO/COOL PATH DUO ABLATION CATHETERS, VERISENSE ENABLED, IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOR AND VERISENSE SYSTEM. THIS DEVICE IS INDICATED FOR USE WITH THE COMPATIBLE IRRIGATION PUMP AND THE1500T9-CP RADIOFREQUENCY (RF) GENERATOR AT A MAXIMUM OF 50 WATTS. THE CATHETERS ARE INTENDED FOR CREATING ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES (MAPPING, STIMULATION AND ABLATION) FOR THE TREATMENT OF TYPICAL ATRIAL FLUTTER.
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