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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 NameCAPSURE FIX MODELS 4067,4068, 4568,5068,5568 PACING LEADS
Classification Namepermanent pacemaker electrode
Generic Namepacing lead
Regulation Number870.3680
ApplicantMEDTRONIC INC., CARDIAC RHYTHM DISEASE MANAGEMENT
PMA NumberP930039
Supplement NumberS005
Date Received03/02/1998
Decision Date09/01/1998
Product Code
DTB[ Registered Establishments with DTB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the capsurefix(r) pacing lead family.
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