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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameMODEL 5071 LEAD
Classification Namepermanent pacemaker electrode
Regulation Number870.3680
PMA NumberP120017
Date Received05/15/2013
Decision Date04/27/2015
Product Code
DTB[ Registered Establishments with DTB ]
Docket Number 15M-1461
Notice Date 05/08/2015
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for unipolar ventricular pacing and sensing. The lead has application where permanent ventricular or dual-chamber pacing systems are indicated. Two leads may be used for bipolar pacing.
Approval Order Approval Order