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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceTENDRIL AND OPTISENSE LEAD FAMILIES
Generic NameDrug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
ApplicantAbbott Medical
15900 Valley View Court
Sylmar, CA 91335
PMA NumberP960013
Supplement NumberS071
Date Received02/14/2012
Decision Date04/13/2012
Product Code NVN 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR MODIFICATION TO THE CONNECTOR BOOT ON THE ISOFLEX TENDRIL ST, TENDRIL STS, AND OPTISENSE LEAD MODELS, TENDRIL ST MODELS 1882, 1888, TENDRIL STS MODELS 1988, 2088 AND OPTISENSE MODEL 1999.
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