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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 (TENDRIL, TENDRIL ST, TENDRIL STS) AND OPTISENSE FAMILY OF LEADS
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 NumberS072
Date Received04/03/2012
Decision Date05/03/2012
Product Code NVN 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
IMPLEMENT ST. JUDE MEDICAL DISTRIBUTION AND LABELING SYSTEM (SDLS) FOR ALL SJM CRMD PRODUCTS.
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