• 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 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.
 
DeviceNAVISTAR RMT THERMOCOOL MAGNETIC STEERING CATHETERS
Classification Namecardiac ablation percutaneous catheter
Generic Namecardiac ablation percutaneous catheter
Applicant
BIOSENSE WEBSTER, INC.
3333 diamond canyon rd.
diamond bar, CA 91765
PMA NumberP030031
Supplement NumberS036
Date Received10/19/2011
Decision Date12/12/2011
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for extending the shelf life from one (1) to three (3) years and for a minor change to the thermofoam tray used to package the devices.
-
-