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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 CAPSURE(R) SP MODEL 5024M/5524M PACING LEADS
Classification Namepermanent pacemaker electrode
Generic Nameelectrode, pacemaker, permanent
Regulation Number870.3680
ApplicantMEDTRONIC VASCULAR
PMA NumberP850089
Supplement NumberS035
Date Received05/08/1996
Decision Date03/07/1997
Product Code
DTB[ Registered Establishments with DTB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the use of nusil med-4719 as an alternate silicone insulator for mdx4-4516.
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