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.
 
DeviceNAVISTAR DS 8 MM DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER AND CELSIUS DS 8 MM DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
ApplicantBIOSENSE WEBSTER, INC.
31 Technology Drive
Suite 200
Irvine, CA 92618
PMA NumberP010068
Supplement NumberS004
Date Received07/28/2004
Decision Date09/10/2004
Product Code OAD 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR AN ALTERNATIVE STERILIZATION METHOD (I.E., EO EXPRESS FOR BIOLOGICAL INDICATOR RELEASE) FOR THE NAVISTAR DS 8MM DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER AND CELSIUS DS 8 MM DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER.
-
-