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Device | MEDTRONIC SYNCHROMED II IMPLANTABLE PROGRAMMABLE INFUSION PUMP SYSTEM |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P860004 |
Supplement Number | S063 |
Date Received | 10/19/2004 |
Decision Date | 11/12/2004 |
Product Code |
LKK |
Advisory Committee |
General Hospital |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement UPDATING THE FINAL FUNCTIONAL TEST SOFTWARE TO REDUCE HUMAN DATA ENTRY ERRORS AND ADDING AN ADDITIONAL EQUIPMENT INTERFACE TO AVOID CALIBRATION CONSTANT ENTRY ERRORS BY MANUFACTURING OPERATORS. |