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 THERMOCOOL, THERMOCOOL EZ STEER and THERMOCOOL SMARTTOUCH
Generic NameCardiac ablation percutaneous catheter
ApplicantBIOSENSE WEBSTER, INC.
31 Technology Drive
Suite 200
Irvine, CA 92618
PMA NumberP040036
Supplement NumberS082
Date Received05/17/2021
Decision Date09/22/2021
Product Code LPB 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for updated labeling, including modified warnings and directions for use.
-
-