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.
 
DeviceEPT-1000 XP CARDIAC ABLATION SYSTEM
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
ApplicantBOSTON SCIENTIFIC
150 BAYTECH DRIVE
SAN JOSE, CA 95134
PMA NumberP020025
Supplement NumberS004
Date Received12/18/2003
Decision Date06/09/2004
Product Code OAD 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR A CHANGE IN DESIGN OF THE EPT-1000 XP CARDIAC ABLATION CONTROLLER. THE CHANGE IN DESIGN INCORPORATES THE ORIGINALLY APPROVED EPT-1000 XP CONTROLLER WITH TRACK WHILE ABLATE (TWA) TECHNOLOGY TO VISUALIZE CATHETER NAVIGATION DURING RF ENERGY DELIVERY USING THE REAL TIME POSITION MANAGEMENT (RPM) SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TRACK WHILE ABLATE (TWA) EPT-1000 XP CARDIAC ABLATION SYSTEM. THE TWA EPT-1000 XP CARDIAC ABLATION CONTROLLER AND ACCESSORIES ARE INDICATED FOR USE IN CONJUNCTION WITH STANDARD AND HIGH POWER CATHETERS FOR CARDIAC ABLATION PROCEDURES.
-
-