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Device | SYNCHROMED, SYNCHROMED EL AND SYNCHROMED II IMPLANTABLE INFUSION SYSTEMS |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P860004 |
Supplement Number | S140 |
Date Received | 09/07/2010 |
Decision Date | 10/07/2010 |
Product Code |
LKK |
Advisory Committee |
General Hospital |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR LABELING CHANGES TO THE SYNCHROMED, SYNCHROMED EL AND SYNCHROMED II IMPLANTABLE INFUSION SYSTEMS TO INCLUDE CEPHALAD MIGRATION OF CATHETER FRAGMENTS ASPART OF THE ADVERSE EVENT SUMMARIES. |