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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 DUO/ SAFIRE BLU DUO ABLATION CATHETER
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
ApplicantAbbott Medical
2375 MORSE AVENUE
Plymouth, MN 55442
PMA NumberP110016
Supplement NumberS003
Date Received06/25/2012
Decision Date07/30/2013
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
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR ADDING A MEDIGUIDE TECHNOLOGY PASSIVE SENSOR INTO THE TIP OF THE DEVICE FOR THE PURPOSES OF AIDING NAVIGATION AND CHANGING THE COOL PATH DUO UNI-DIRECTIONAL (UNI-D) HANDLE TO A COOL PATH DUO BI-DIRECTIONAL (BI-D) HANDLE. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES COOL PATH DUO ABLATION CATHETER, MEDIGUIDE ENABLED AND SAFIRE DUO ABLATION CATHETER, MEDIGUIDE ENABLED AND ARE INDICATED FOR CREATING ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES (MAPPING, STIMULATION, AND ABLATION) FOR THE TREATMENT OF TYPICAL ATRIAL FLUTTER. THE CATHETERS ARE INTENDED FOR USE WITH A COMPATIBLE EXTERNAL PUMP AND THE IBI-1500T9-CP RF GENERATOR AT A MAXIMUM OF 50 WATTS. MEDIGUIDE ENABLED ABLATION CATHETERS ARE USED WITH THE MEDIGUIDE TECHNOLOGY TO ENABLE REAL-TIME TIP POSITIONING AND NAVIGATION. THE MEDIGUIDE TECHNOLOGY IS INDICATED FOR USE AS AN ADJUNCT TO FLUOROSCOPY.
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