|
Device | SYNCHROMED INFUSION SYSTEM |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P860004 |
Supplement Number | S084 |
Date Received | 05/08/2006 |
Decision Date | 06/09/2006 |
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 AN UPDATE TO THE MODEL 8840 N VISION PROGRAMMER GUIDE REGARDING THE REPOSITIONING AND REPEATING OF AN EXISTING WARNING. |