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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.
 
DeviceLOCATOR STEERABLE STYLET MODEL 4036
Generic Namepermanent pacemaker Electrode
Regulation Number870.3680
ApplicantAbbott Medical
15900 Valley View Court
Sylmar, CA 91335
PMA NumberP960013
Supplement NumberS002
Date Received12/12/1997
Decision Date06/15/1998
Product Code DTB 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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