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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.
Classification Namecardiac ablation percutaneous catheter
PMA NumberP950005
Date Received04/03/1995
Decision Date09/30/1997
Product Code
LPB[ Registered Establishments with LPB ]
Docket Number 98M-0678
Notice Date 09/08/1998
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
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 S052