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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.
 
DeviceINTELLANAV XP TEMPERATURE ABLATION CATHETER, INTELLANAV MIFI XP TEMPERATURE ABLATION CATHETER, INTELLANAV ABLATION CATHE
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
ApplicantBOSTON SCIENTIFIC
150 BAYTECH DRIVE
SAN JOSE, CA 95134
PMA NumberP020025
Supplement NumberS077
Date Received07/24/2015
Decision Date02/24/2016
Product Code OAD 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for design changes to incorporate a magnetic sensor into the IntellaTip XP and MiFi XP Temperature Ablation Catheters. The device, as modified, will be marketed under the trade name IntellaNav Xp Temperature Ablation Catheter and IntellaNav MiFi XP Temperature Ablation Catheter.
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