Premarket Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

• Device: MODEL 5071 LEAD
• Generic Name: permanent pacemaker Electrode
• Regulation Number: 870.3680
• Applicant: MEDTRONIC Inc.; 8200 CORAL SEA STREET NE; MS MV S11; MOUNDS VIEW, MN 55112
• PMA Number: P120017
• Date Received: 10/04/2012
• Decision Date: 04/27/2015
• Product Code: DTB
• Docket Number: 15M-1461
• Notice Date: 05/08/2015
• Advisory Committee: Cardiovascular
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement  
APPROVAL FOR UNIPOLAR VENTRICULAR PACING AND SENSING. THE LEAD HASAPPLICATION WHERE PERMANENT VENTRICULAR OR DUAL-CHAMBER PACING SYSTEMS ARE INDICATED. TWO LEADS MAY BE USED FOR BIPOLAR PACING.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling
• Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 ; S012 S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 ; S024 S025 S026 S027 S028 S029 S030 S031 S032 S033 S034 S035