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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 OPEN-IRRIGATED ABLATION CATHETER
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
ApplicantBoston Scientific Corp.
150 BAYTECH DRIVE
SAN JOSE, CA 95134
PMA NumberP150005
Supplement NumberS008
Date Received05/02/2016
Decision Date03/02/2017
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 three mini electrodes into the Blazer Open Irrigated Ablation Catheter. The device, as modified, will be marketed under the trade name IntellaTip MiFi Open-Irrigated Ablation Catheter and is indicated for: The IntellaTip MiFi Open-Irrigated Ablation Catheter, when used with a Maestro 4000 Radiofrequency (RF) Controller and MetriQ Irrigation Pump, is indicated for cardiac electrophysiological mapping, delivering diagnostic pacing stimuli, and radiofrequency ablation of sustained or recurrent Type I Atrial Flutter (AFL) in patients age 18 or older.
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