|
Device | SYNCHROMED II & ISOMED IMPLANTABLE INFUSION PUMPS |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P860004 |
Supplement Number | S120 |
Date Received | 01/28/2010 |
Decision Date | 02/26/2010 |
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 FOR CHANGES TO THE SYNCHROMED II INFUSION SYSTEM PATIENT MANUAL. |