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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/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.
 
DeviceWEBSTER DIAG./ABLATION DEFLECTABLE TIP CATHETER
Generic NameCardiac ablation percutaneous catheter
ApplicantBiosense Webster, Inc
31 Technology Drive
Suite 200
Irvine, CA 92618
PMA NumberP950005
Date Received04/03/1995
Decision Date09/30/1997
Product Code LPB 
Docket Number 98M-0678
Notice Date 09/08/1998
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the Cordis Webster Diagnostic/Ablation Deflectable Tip Catheter. This device includes the following models: six curve types (A, B, C, D, E, and F); tip electrode (4mm tip large and grooved); connector type [Redel 10-pin connector (temperature sensing version) and Nexus plug (non-temperature-sensing version)]; spacing [standard 2-5-2 spacing (center to center measurement of ring electrode spacing)]. This device is indicated for cardiac electrophysiological mapping and for use with a compatible RF generator for: interruption of accessory atrioventricular (AV) condution pathways associated with tachycardia; the treatment of AV nodal re-entrant tachycardia; and, creation of complete AV nodal block in patients with a difficult to control ventricular response to an atrial arrhythmia.
Supplements:  S001 S002 S003 S004 S006 S007 S008 S009 S010 S011 S012 
S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 S024 
S025 S026 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 S072 S073 
S074 S075 S076 S077 S078 S079 S080 S081 S082 S083 S084 S085 
S086 
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