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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.
 
DeviceCARBON TIPPED LEAD MODELS 1085S,1085M,& 1085K
Generic Namepermanent pacemaker Electrode
Regulation Number870.3680
ApplicantPacesetter Systems
15900 Valley View Ct.
P.O. Box 9221
Sylmar, CA 91392
PMA NumberP800041
Supplement NumberS009
Date Received03/14/1990
Decision Date12/10/1990
Product Code DTB 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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