• 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
St. Jude Medical, Inc.
2375 morse avenue
irvine, CA 92614-6233
PMA NumberP110016
Supplement NumberS006
Date Received01/24/2013
Decision Date04/18/2013
Product Code
OAD[ Registered Establishments with OAD ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Aproval for a modified catheter using a tip electrode with 12 irrigation holes from the currently approved safire blu duo bi-directional ablation catheter with the shaft and handle of the currently approved therapy cool path bi-directional ablation catheter. The device, as modified, will be marketed under the trade name therapy cool path duo bi-directional catheter and is indicated for use with the compatible irrigation pump and 1500t9 cp radiofrequency (rf) generator at a maximum of 50 watts. The catheter is intended for creating endocardial lesions during cardiac ablation procedures (mapping, stimulation, and ablation) for the treatment of typical atrial flutter.