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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 NameTHINLINE II STEROX, FINELINE II STEROX & FINELINE II STEROX EZ LEADS
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 NumberS050
Date Received02/01/2012
Decision Date02/29/2012
Product Code
NVN[ Registered Establishments with NVN ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to the bacterial endotoxin sampling plan.
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