|
Device | SYNCHROMED EL/SYNCHROMED II/ISOMED PUMPS |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P990034 |
Supplement Number | S020 |
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 TO UPDATE THE LABELING FOR THESE DEVICES TO SPECIFICALLY STATE CEPHALAD MIGRATION OF CATHETER FRAGMENTS AS PART OF THE ADVERSE EVENT SUMMARIES IN THE DEVICES¿ INFORMATION FOR PRESCRIBERS MANUALS AND USER MANUALS. |