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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 NameSELUTE STEROID ELUTING ENDOCARDIAL LEAD MODELS 4185 & 4285
Classification Namedrug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes
Generic Nametransvenous unipolar/bipolar pacing lead
ApplicantBOSTON SCIENTIFIC
PMA NumberP950001
Date Received01/13/1995
Decision Date05/08/1996
Product Code
NVN[ Registered Establishments with NVN ]
Docket Number 96M-0371
Notice Date 10/24/1996
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product Yes
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 
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