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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 SP MODEL 5024M
Classification Namepermanent pacemaker electrode
Generic Namepacing lead
Regulation Number870.3680
ApplicantMEDTRONIC VASCULAR
PMA NumberP930039
Supplement NumberS013
Date Received11/14/2001
Decision Date12/19/2001
Product Code
DTB[ Registered Establishments with DTB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason other
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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