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) | Registration & Listing | Adverse Events | Recalls | PMA | 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.
 
Trade NameLIVEWIRE TC CARDIAC ABLATION CATHETER
Classification Namecardiac ablation percutaneous catheter
Generic Nameradio frequency-powered cardiac catheter ablation system
ApplicantST. JUDE MEDICAL
PMA NumberP960016
Supplement NumberS003
Date Received06/28/1999
Decision Date12/13/1999
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason location change: sterilizer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in sterilization process from 12% eto/88% cfc to 100% eto (while at the same time transferring the sterilization to an outside contract sterilization facility).
-
-