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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.
 
DeviceSELUTE STEROID ELUTING ENDOCARDIAL LEAD MODELS 4185 & 4285
Generic NameDrug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
ApplicantBOSTON SCIENTIFIC
4100 Hamline Avenue North
St. Paul, MN 55112
PMA NumberP950001
Date Received01/13/1995
Decision Date05/08/1996
Product Code NVN 
Docket Number 96M-0371
Notice Date 10/24/1996
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR THE SELUTE STEROID ELUTING ENDOCARDIAL LEAD MODELS 4185 AND 4285
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S015 S016 S017 S020 S021 S022 S023 S024 S025 
S026 S027 S028 S029 
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