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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 SDX
Generic Namepermanent pacemaker Electrode
Regulation Number870.3680
ApplicantAbbott Medical
15900 Valley View Court
Sylmar, CA 91335
PMA NumberP960013
Supplement NumberS009
Date Received11/16/2000
Decision Date12/07/2000
Product Code DTB 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE FOLLOWING MODIFICATIONS TO THE SUTURE SLEEVES USED WITH THE PACEMAKER LEADS: THE INCORPORATION OF TITANIUM DIOXIDE INTO THE SUTURE SLEEVE MATERIAL TO MAKE THE MATERIAL "MORE VISIBLE DURING IMPLANT"; INCREASING THE INNER DIAMETER OF THE SLEEVE AND; REMOVEL OF THE SLEEVE EYELET'S.
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