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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Trade NameENDOCARDIAL PACEMAKER LEAD W/CARBON TIP
Classification Namepermanent pacemaker electrode
Generic Namepacemaker, lead, cardiac
Regulation Number870.3680
ApplicantPACESETTER SYSTEMS
PMA NumberP800041
Supplement NumberS001
Date Received12/17/1982
Decision Date01/27/1983
Product Code
DTB[ Registered Establishments with DTB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason other
Expedited Review Granted? No
Combination Product No
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