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 NameEPT-1000 CARDIAC ABLATION SYSTEM
Classification Namecardiac ablation percutaneous catheter
Generic Nameelectrode,percutaneous,conduction tissue ablation
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP920047
Supplement NumberS017
Date Received08/07/2002
Decision Date09/27/2002
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for revised indications for use for the steerocath-t, polaris-t, and blazer ii ablation catheters, which are components of the ept-1000 cardiac ablation system. The catheters are indicated for creating endocardial lesions during cardiac ablation procedures to treat arrhythmia.
-
-