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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.
 
DeviceCAPSUREFIX(R)
Generic Namepermanent pacemaker Electrode
Regulation Number870.3680
ApplicantMedtronic, Inc.
8200 CORAL SEA STREET N.E.
MOUNDS VIEW, MN 55112
PMA NumberP930039
Supplement NumberS009
Date Received03/13/2000
Decision Date08/31/2000
Product Code DTB 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR AN EXTENDABLE/RETRACTABLE SCREW-IN PACING LEAD. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES MEDTRONIC CAPSURE(R)FIX NOVUS MODEL 5076 AND VITATRON CRYSTALLINE(R) ACTFIX MODEL ICF09 PACING LEADS. THESE DEVICES ARE INDICATED FOR PERMANENT PACING AND SENSING OF THE VENTRICLE AND/OR ATRIUM WHEN USED WITH A COMPATIBLE PULE GENERATOR.
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