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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 ATTAIN ABILITY MODEL 4196 LEAD
Classification Namedrug eluting permanent left ventricular (lv) pacemaker electrode
Applicant MEDTRONIC INC.
PMA NumberP080006
Date Received03/14/2008
Decision Date04/07/2009
Product Code
OJX[ Registered Establishments with OJX ]
Docket Number 09M-0182
Notice Date 04/10/2009
Advisory Committee Cardiovascular
Clinical Trials NCT00271544
Expedited Review Granted? No
Combination Product Yes
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the attain ability model 4196 lead. The attain ability model 4196 steroid eluting, dual electrode, is-1 transvenous lead is indicated for chronic pacing and sensing in the left ventricle via the cardiac vein, when used in conjunction with a compatible medtronic cardiac resynchronization therapy (crt) system. Extended bipolar pacing is available using this lead in combination with a compatible crt-d system and rv defibrillation lead or with a compatible crt-p system and rv pacing lead.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S016 S017 S018 S019 
S020 S021 S022 S023 S024 S025 S026 S027 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 S064 S065 
S066 S067 
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