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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 NameMEDTRONIC (R) CAPSURE (R) EPI PACING LEAD MODEL 4695
Classification Namepermanent pacemaker electrode
Generic Namecapsure epi epicardial steroid eluting pacing lead
Regulation Number870.3680
ApplicantMEDTRONIC VASCULAR
PMA NumberP950024
Supplement NumberS004
Date Received07/17/2001
Decision Date08/08/2001
Product Code
DTB[ Registered Establishments with DTB ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in the supplier of polyetherurethane.
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