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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.
 
DeviceBlazer Open-Irrigated and IntellaNav Open-Irrgated Ablation Catheters
Classification Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Applicant
Boston Scientific Corp.
150 baytech drive
san jose, CA 95134
PMA NumberP150005
Supplement NumberS035
Date Received02/02/2018
Decision Date08/01/2018
Product Code
OAD[ Registered Establishments with OAD ]
Advisory Committee Cardiovascular
Clinical Trials NCT01687166
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for expanded indications for use to include the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation. The devices, as modified, will be marketed under the trade name IntellaTip MiFi Open-Irrigated Ablation Catheter and IntellaNav MiFi Open-Irrigated Ablation Catheter when used with a compatible Radiofrequency Controller and Irrigation Pump, are indicated for cardiac electrophysiological mapping, delivering diagnostic pacing stimuli, radiofrequency ablation of sustain or recurrent Type 1 Atrial Flutter in patients age 18 or older, and treatment of drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation (PAF) in patients age 18 years or older, when used with a compatible mapping system.
Post-Approval StudyShow Report Schedule and Study Progress
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