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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 Namedrug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes
Generic Nameelectrode, pacemaker, permanent and temporary
PMA NumberP960004
Date Received01/29/1996
Decision Date11/12/1996
Product Code
NVN[ Registered Establishments with NVN ]
Docket Number 97M-0258
Notice Date 07/02/1997
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the thinline(tm) models 430-10 and 432-04 endocardial pacing leads indicated for chronic pacing and sensing of the atrium or ventricle when used with a compatible pulse generator.
Supplements: S001 S002 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S015 S017 S018 S019 S020 S021 
S022 S023 S024 S025 S026 S027 S028 S029 S030 
S031 S032 S034 S035 S036 S038 S039 S041 S042 
S044 S045 S046 S048 S049 S050 S051 S052 S053 
S054 S055 S056 S057 S058 S060 S061 S063 S064 
S065 S066 S067 S068 S069 S070 S072