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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceACUITY SPIRAL HEART FAILURE LEAD MODELS, 4591, 4592 AND 4593
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Nameimplantable pulse generator, pacemaker (non-crt)
Applicant
Boston Scientific Corp.
4100 hamline ave north
st. paul, MN 55112
PMA NumberP010012
Supplement NumberS160
Date Received10/09/2007
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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