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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 CAPSUREEPI 4695 AND CAPSUREEPI 4968
Classification Namepermanent pacemaker electrode
Generic Namecapsure epi epicardial steroid eluting pacing lead
Regulation Number870.3680
ApplicantMEDTRONIC VASCULAR
PMA NumberP950024
Supplement NumberS006
Date Received12/24/2002
Decision Date05/09/2003
Product Code
DTB[ Registered Establishments with DTB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for material and labeling changes for various medtronic and vitatron pacing and defibrillator leads.
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