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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 NameTHIN/LINE/FINELINE FAMILY OF ENDOCARDIAL PACING LEADS
Classification Namedrug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes
Generic Nameactive fixation transvenous bipolar pacing lead
ApplicantBOSTON SCIENTIFIC
PMA NumberP960004
Supplement NumberS066
Date Received06/30/2014
Decision Date07/30/2014
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 No
Approval Order Statement 
Change in the bioburden sampling frequency in the clonmel and st paul facilities for the devices.
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