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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.
 
DeviceINTELLATIP MIFI XP- ABLATION CATHETER AND BLAZER PRIME XP CATHETER
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
ApplicantBOSTON SCIENTIFIC
4100 Hamline Avenue North
St Paul, MN 55112
PMA NumberP020025
Supplement NumberS036
Date Received11/02/2012
Decision Date08/07/2013
Product Code OAD 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR BLAZER PRIME XP CATHETER DESIGN MODIFICATIONS, MATERIAL PACKAGING, LABELING CHANGES, AND ADDITION OF ACCESSORIES: INTELLATIP MIFI CABLE, FILTER MODULE, AND REFERENCE CABLE FOR THE INTELLATIP MIFI FAMILY OF CATHETERS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME INTELLATIP MIFI XP ABLATION CATHETER AND IS INDICATED FOR USE WITH THE BSC MAESTRO 3000 CARDIAC ABLATION CONTROLLER AND ACCESSORIES FOR THE TREATMENT OF SUSTAINED OR RECURRENT TYPE I ATRIAL FLUTTER IN PATIENTS AGE 18 OR OLDER. THE BSC HIGH POWER CARDIAC ABLATION CONTROLLER AND ACCESSORIES ARE INDICATED FOR USE IN CONJUNCTION WITH STANDARD AND HIGH POWER CATHETERS FOR CARDIAC ABLATION PROCEDURES.
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