|
Device | MEDTRONIC 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 | S038 |
Date Received | 05/28/1997 |
Decision Date | 09/18/1997 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement Approval for the inclusion of an add'l precaution regarding the complications associated with the development of an "inflammatory mass" at the tip of the implanted catheter to the SynchroMed Infusion System Techinical Manual and the Model 8703W InDura Intraspinal Catheter Technical Manual. |