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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameNAVISTAR/CELSIUS DS DIAGNOSTIC/ABLATION DEFLECTABLE 8MM TIP CATHETER
Classification Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Generic Nameradiofrequency ablation catheter; electrode recording catheter
ApplicantBIOSENSE WEBSTER, INC.
PMA NumberP010068
Date Received12/31/2001
Decision Date09/27/2002
Product Code
OAD[ Registered Establishments with OAD ]
Docket Number 03M-0049
Notice Date 02/10/2003
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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 Order Approval Order
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 S033 
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