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 NameE P TECH EPT-1000 CARDIAC ABLATION SYSTEM
Classification Namecardiac ablation percutaneous catheter
Generic Namecardiac ablation
ApplicantEP TECHNOLOGIES, INC.
PMA NumberP920047
Supplement NumberS004
Date Received01/12/1995
Decision Date08/14/1995
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Relocation of one of the contract manufacturers (seamed corporation) who manufacturers the ept-1000 rf generator.
-
-