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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameSUREFIX TM MODEL 5072 LEAD
Classification Namepermanent pacemaker electrode
Generic Namepacing lead
Regulation Number870.3680
ApplicantMEDTRONIC INC., CARDIAC RHYTHM DISEASE MANAGEMENT
PMA NumberP930039
Supplement NumberS004
Date Received11/17/1997
Decision Date06/03/1998
Product Code
DTB[ Registered Establishments with DTB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the surefix(tm) model 5072 steroid-eluting screw-in pacing lead with a non-retractable helix. The device, as modified, will be marketed under the trade name surefix(tm) model 5072 pacing lead and is designed to be used with a pulse generator as part of a cardiac pacing system. The lead has application where implantable atrial or ventricular, single chamber or dual chamber pacing systems are indicated.
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