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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.
 
DeviceTENDRILL PASSIVE PLUS/AU PLUS DX
Generic Namepermanent pacemaker Electrode
Regulation Number870.3680
ApplicantABBOTT MEDICAL
15900 Valley View Ct.
Sylmar, CA 91335
PMA NumberP960030
Supplement NumberS008
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
Predetermined Change Control Plan AuthorizedNo
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 MATGERIAL TO MAKE THE MATERIAL "MORE VISIBLE DURING IMPLANT"; INCREASING THE INNER DIAMETER OF THE SLEEVE AND; REMOVAL OF THE SLEEVE EYELET'S.
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