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.
 
DeviceSTOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR
Generic NameCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
Regulation Number870.1220
ApplicantBiosense Webster, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP990071
Supplement NumberS005
Date Received12/22/2003
Decision Date06/06/2005
Product Code DRF 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR MANUAL OPERATION OF THE COOLFLOW IRRIGATION PUMP WITH THE BIOSENSE WEBSTER THERMOCOOL CATHETERS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME COOLFLOW IRRIGATION PUMP. THE COOLFLOW IRRIGATION PUMP AND TUBING SET IS A PERISTALTIC IRRIGATION PUMP DESIGNED FOR THE DELIVERY OF SALINE SOLUTION WHEN USED IN CONJUNCTION WITH THE STOCKERT 70 RF GENERATOR AND THE THERMOCOOL IRRIGATION CATHETERS.
-
-