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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 NameMEDTRONIC(R) CAPSURE(R) EPI PACING LEAD MODEL 4695
Classification Namedrug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes
Generic Namecapsure epi epicardial steroid eluting pacing lead
Applicant MEDTRONIC INC.
PMA NumberP950024
Date Received07/17/1995
Decision Date09/06/1996
Product Code
NVN[ Registered Establishments with NVN ]
Docket Number 97M-0273
Notice Date 07/08/1997
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the capsure epi pacing lead, model 4965.
Supplements: S001 S002 S003 S004 S005 S006 
S007 S008 S009 S010 S011 S013 
S015 S016 S017 S018 S019 S020 
S021 S022 S023 S024 S026 S027 
S028 S029 S030 S031 S032 S033 
S034 S035 S036 S037 S038 S039 
S040 S041 S042 S043 S044 S045 
S046 S047 
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