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.
 
DeviceSAFIRE CARDIAC ABLATION SYSTEM
Generic NameCardiac ablation percutaneous catheter
ApplicantSt. Jude Medical
14900 MINNETONKA IND RD
MINNETONKA, MN 55345
PMA NumberP960016
Supplement NumberS019
Date Received08/07/2007
Decision Date09/24/2007
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
Approval Order Statement  
APPROVAL FOR LABELING MODIFICATIONS THAT ALLOWS: 1) THE IBI-1500T6 AND T9 CARDIAC ABLATION GENERATORS (EQUIPPED WITH TEMPERATURE MONITORING) TO BE USED WITH THE SAFIRE BI-DIRECTIONAL ABLATION CATHETER AND 2) THE EXTENSION CABLES (PREVIOUSLY APPROVED UNDER P960016/S016 FOR USE WITH THE IBI-1500T6) BE USED WITH THE IBI-1500 T9 RF GENERATOR.
-
-