• 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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
150 baytech drive
san jose, CA 95134
PMA NumberP020025
Supplement NumberS036
Date Received11/02/2012
Decision Date08/07/2013
Product Code
OAD[ Registered Establishments with OAD ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Recalls CDRH 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.