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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 NameFINELINE II STEROX
Classification Namedrug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes
Generic Nameactive fixation transvenous bipolar pacing lead
ApplicantBOSTON SCIENTIFIC-CRM
PMA NumberP960004
Supplement NumberS064
Date Received11/08/2013
Decision Date12/04/2013
Product Code
NVN[ Registered Establishments with NVN ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Removal of two redundant inspections at the manufacturing site for fineline ii leads.
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