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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceACUITY STEERABLE LEAD SYSTEM
Generic NameDrug eluting permanent left ventricular (lv) pacemaker electrode
ApplicantGUIDANT CORP.
4100 HAMLINE AVENUE NORTH
ST. PAUL, MN 55112-5798
PMA NumberP050046
Date Received10/14/2005
Decision Date04/13/2007
Product Code OJX 
Docket Number 07M-0154
Notice Date 04/19/2007
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR THE ACUITY STEERABLE LEAD MODELS 4554, 4555, AND 4556. THE GUIDANT ACUITY STEERABLE IS-1 CORONARY VENOUS, STEROID-ELUTING, DUAL-ELECTRODE PACE/SENSE LEADS ARE TRANSVENOUS LEADS INTENDED FOR CHRONIC, LEFT-VENTRICULAR PACING AND SENSING VIA THE CORONARY VEINS WHEN USED IN CONJUNCTION WITH A COMPATIBLE PULSE GENERATOR. EXTENDED BIPOLAR PACING AND SENSING IS AVAILABLE USING ACUITY STEERABLE WITH AN RV PACE/SENSE/DEFIBRILLATION LEAD OR A BIPOLAR RV PACE/SENSE LEAD.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S009 S010 S011 S014 S019 S022 S024 S018 S025 S015 S004 
S012 S021 S023 S026 S016 S017 S013 S020 S003 S007 S002 S005 
S006 S032 S029 S028 S030 S031 
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