|
Device | IMPLANTABLE INFUSION SYSTEM |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P860004 |
Supplement Number | S162 |
Date Received | 11/04/2011 |
Decision Date | 12/12/2011 |
Product Code |
LKK |
Advisory Committee |
General Hospital |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement RELOCATION OF PASSIVATION OPERATIONS AND INTRODUCTION OF AN AUTOMATED FLUID TRANSFER PROCESS WITHIN THE EXISTING MEDTRONIC NEUROMODULATION FACILITY ¿ RICE CREEK CENTRAL. |