|
Device | MEDTRONIC MODEL 8472 ISOMED CONSTANT-FLOW PUMP (ISOMED PUMP) |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P990034 |
Supplement Number | S013 |
Date Received | 07/09/2009 |
Decision Date | 08/06/2009 |
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 AN ERRATA INSERT COMMUNICATING THE INCOMPATIBILITY ISSUE OF THE SUTURELESS CONNECTORS TO THE MODEL 8472 ISOMED CONSTANT-FLOW PUMP. |