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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceMEDTRONIC CAPSURE SP MODEL 5024M
Generic Namepermanent pacemaker Electrode
Regulation Number870.3680
ApplicantMedtronic, Inc.
8200 Coral Sea St. N.E
Mounds View, MN 55112
PMA NumberP930039
Supplement NumberS013
Date Received11/14/2001
Decision Date12/19/2001
Product Code DTB 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Other
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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