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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameACUITY SPIRAL HEART FAILURE LEAD MODELS, 4591, 4592 AND 4593
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Namepulse generator
ApplicantGUIDANT CORP.
PMA NumberP010012
Supplement NumberS160
Date Received11/01/2007
Decision Date05/16/2008
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the acuity spiral lead model 4591, 4592, and 4593. The device is indicated for chronic, left-ventricular pacing and sensing via the coronary veins when used in conjunction with a compatible pulse generator.
Post-Approval StudyShow Report Schedule and Study Progress
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