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.
 
DeviceLIVEWIRE TC CARDIAC ABLATION SYSTEM
Generic NameCardiac ablation percutaneous catheter
ApplicantSt Jude Medical
14900 Minnetonka Ind Rd.
Minnetonka, MN 55345
PMA NumberP960016
Supplement NumberS008
Date Received08/08/2002
Decision Date09/27/2002
Product Code LPB 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR REVISED INDICATIONS FOR USE FOR LIVEWIRE TC ABLATION CATHETERS. THE CATHETERS ARE INDICATED FOR CARDIAC ELECTROPHYSIOLOGICAL MAPPING AND FOR USE WITH A COMPATIBLE RF GENERATOR FOR CREATING ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES TO TREAT ARRHYTHMIAS.
-
-