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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.
 
DeviceSYNCHROMED II PROGRAMMABLE DRUG INFUSION SYSTEM
Generic NamePump, infusion, implanted, programmable
ApplicantMedtronic, Inc.
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP860004
Supplement NumberS060
Date Received03/24/2004
Decision Date03/29/2004
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
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE FOLLOWING CHANGES INVOLVING THE MOTOR COIL FOR THE SYNCHROMED II IMPLANTABLE INFUSION PUMP: 1) CHANGE FROM A CRIMPED TO A HEAT-WELDED MOTOR COIL CONNECTOR PIN; AND 2) CHANGE TO A SILICON VARNISH SURFACE COATING OF THE MOTOR COIL, THE SAME COATING AS APPLIED TO THE MOTOR COIL OF THE SYNCHROMED EL IMPLANTABLE INFUSION PUMP.
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