|
Device | SYNCHROMED II PROGRAMMABLE DRUG INFUSION SYSTEM |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P860004 |
Supplement Number | S060 |
Date Received | 03/24/2004 |
Decision Date | 03/29/2004 |
Product Code |
LKK |
Advisory Committee |
General Hospital |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH 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. |