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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 
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S038 S039 S040 S041 S042 S043 
S044 S045 S046 S047 S048 S049 
S050 S051 S053 
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