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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 SYNCHROMED II IMPLANTABLE PROGRAMMABLE DRUG INFUSION SYSTEM
Generic NamePump, infusion, implanted, programmable
ApplicantMedtronic, Inc.
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP860004
Supplement NumberS077
Date Received09/30/2005
Decision Date11/22/2005
Product Code LKK 
Advisory Committee General Hospital
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE FOLLOWING MODIFICATIONS: 1) CHANGE THE COMPOSITION OF THE MOTOR COIL PIN CONNECTOR MATERIAL FROM A PHOSPHOR BRONZE CONTAINING SOME LEAD TO A LEAD-FREE PHOSPHOR BRONZE; AND 2) MODIFY THE WELD COATING PROCESS FROM ONE LARGE MOUND OF SILICONE VARNISH OVER BOTH MOTOR COIL CONNECTOR PINS TO INDIVIDUAL MOUNDS OVER EACH PIN.
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