Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
ApplicantBoston Scientific Corp.
150 BAYTECH DRIVE
SAN JOSE, CA 95134
PMA NumberP150005
Supplement NumberS035
Date Received02/02/2018
Decision Date08/01/2018
Product Code OAD 
Advisory Committee Cardiovascular
Clinical TrialsNCT01687166
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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
-
-