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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 MODEL 5076 LEAD
Classification Namepermanent pacemaker electrode
Generic Namepacing lead
Regulation Number870.3680
ApplicantMEDTRONIC VASCULAR
PMA NumberP930039
Supplement NumberS018
Date Received02/10/2004
Decision Date03/10/2004
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 Yes
Approval Order Statement 
Use of med-2000 silicone adhesive as an alternative for med-1137 silicone adhesive.
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