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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 NameMEDTRONIC SELECTSECURE LEAD MODEL 3830
Classification Namedrug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes
Generic Namepacing lead
ApplicantMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
PMA NumberP030036
Date Received09/10/2003
Decision Date08/03/2005
Product Code
NVN[ Registered Establishments with NVN ]
Docket Number 05M-0380
Notice Date 09/23/2005
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product Yes
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the selectsecure lead model 3830. The model 3830 lead has applications where implantable atrial or ventricular, single-chamber or dual-chamber pacing systems are indicated. The model 3830 lead is intended for pacing and sensing in the atrium or ventricle.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S016 S017 S018 
S019 S020 S021 S022 S024 S025 S026 S027 S028 
S029 S030 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 S061 S062 S063 S064 S065 S066 
S067 S068 S069 S070 S071 
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