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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 S031 S032 S033 S034 S035 S036 S037 S038 
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