|
Device | SYNCHROMED PUMP AND INFUSION SYSTEM |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P860004 |
Supplement Number | S191 |
Date Received | 04/25/2013 |
Decision Date | 05/23/2013 |
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 OF LABELING CHANGES FOR DEVICE REFILL KIT MODEL 8551 TO ACCOMMODATE THE POSSIBILITY FOR THE USE OF MULTIPLE SYRINGES DURING KIT REFILL PROCEDURES. |