• 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 has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceNAVISTAR/CELSIUS DS DIAGNOSTIC/ABLATION DEFLECTABLE 8MM TIP CATHETER
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
ApplicantBIOSENSE WEBSTER, INC.
31 Technology Drive
Suite 200
Irvine, CA 92618
PMA NumberP010068
Date Received12/31/2001
Decision Date09/27/2002
Product Code OAD 
Docket Number 03M-0049
Notice Date 02/10/2003
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE NAVISTAR DS AND CELSIUS DS DIAGNOSTIC/ABLATION CATHETERS, STOCKERT 70 GENERATOR AND ACCESSORIES. THE NAVISTAR DS AND CELSIUS DS CATHETERS AND RELATED ACCESSORY DEVICES ARE INDICATED FOR CATHETER-BASED CARDIAC ELECTROPHYSIOLOGICAL MAPPING (STIMULATION AND RECORDING), AND FOR USE WITH THE STOCKERT 70 (MODEL S7001 WITH SOFTWARE VERSION 001/033) FOR THE TREATMENT OF TYPE I ATRIAL FLUTTER IN PATIENTS AGE 18 OR OLDER. THE NAVISTAR DS CATHETER PROVIDES LOCATION INFORMATION WHEN USED WITH THE CARTO EP NAVIGATION SYSTEM.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S017 S018 S019 S020 S021 S022 S023 S024 S025 
S026 S027 S028 S029 S030 S031 S032 S033 S034 S035 S036 S037 
S038 S039 S040 S041 S042 S043 S044 S045 S046 S047 S048 S049 
S050 S051 S052 S053 S054 S055 S056 S057 S058 S059 S060 S061 
S062 S063 S064 S065 S066 S067 S068 S069 S070 S071 
-
-