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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.
 
DeviceBI-DIRECTIONAL THERAPY COOL PATH DUO IRRIGATED ABLATION CATHETERS
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
ApplicantABBOTT MEDICAL
2375 Morse Ave.
Plymouth, MN 55442
PMA NumberP110016
Supplement NumberS006
Date Received01/24/2013
Decision Date04/18/2013
Product Code OAD 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APROVAL FOR A MODIFIED CATHETER USING A TIP ELECTRODE WITH 12 IRRIGATION HOLES FROM THE CURRENTLY APPROVED SAFIRE BLU DUO BI-DIRECTIONAL ABLATION CATHETER WITH THE SHAFT AND HANDLE OF THE CURRENTLY APPROVED THERAPY COOL PATH BI-DIRECTIONAL ABLATION CATHETER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME THERAPY COOL PATH DUO BI-DIRECTIONAL CATHETER AND IS INDICATED FOR USE WITH THE COMPATIBLE IRRIGATION PUMP AND 1500T9 CP RADIOFREQUENCY (RF) GENERATOR AT A MAXIMUM OF 50 WATTS. THE CATHETER IS INTENDED FOR CREATING ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES (MAPPING, STIMULATION, AND ABLATION) FOR THE TREATMENT OF TYPICAL ATRIAL FLUTTER.
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