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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 NameACUITY STEERABLE LEAD MODELS 4554, 4555 AND 4556
Classification Namedrug eluting permanent left ventricular (lv) pacemaker electrode
ApplicantGUIDANT CORP.
PMA NumberP050046
Date Received10/14/2005
Decision Date04/13/2007
Product Code
OJX[ Registered Establishments with OJX ]
Docket Number 07M-0154
Notice Date 04/19/2007
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 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 Order Approval Order
Supplements: S002 S003 S004 S005 S006 S007 
S009 S010 S011 S012 S013 S014 
S015 S016 S017 S018 S019 
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