|
Device | ISOMED FIXED RATE INFUSION PUMP |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P990034 |
Supplement Number | S005 |
Date Received | 12/10/2004 |
Decision Date | 12/23/2004 |
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 | No |
Approval Order Statement APPROVAL FOR CHANGES TO THE ISOMED FIXED RATE INFUSION PUMP TECHNICAL MANUAL FOR NEW WARNINGS AND INFORMATION REGARDING INFLAMMATORY MASS AND OTHER TEXT CHANGES. |