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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameCARBON TIPPED LEAD MODELS 1085S,1085M,& 1085K
Classification Namepermanent pacemaker electrode
Generic Nameelectrode, pacemaker, permanent
Regulation Number870.3680
PMA NumberP800041
Supplement NumberS011
Date Received03/29/1991
Decision Date05/25/1994
Product Code
DTB[ Registered Establishments with DTB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No