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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 SP MODEL 5024M AND SUREFIX MODEL 5072 LEADSRIES
Classification Namepermanent pacemaker electrode
Generic Nameelectrode, pacemaker, permanent
Regulation Number870.3680
ApplicantMEDTRONIC VASCULAR
PMA NumberP850089
Supplement NumberS050
Date Received11/14/2001
Decision Date12/19/2001
Product Code
DTB[ Registered Establishments with DTB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the following: 1) a change in outer insulation treatment from silacure to siloxane for the capsure sp model 5024m lead; 2) a material change from mdx silicone to med 4719 silicone for surefix model 5072 inner and outer insulation (outer insulation with siloxane treatment); and 3) associated minor labeling changes.
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