|
Device | SPINAL CORD STIMULATION (SCS) |
Generic Name | Stimulator, spinal-cord, totally implanted for pain relief |
Applicant | MEDTRONIC NEUROMODULATION 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432 |
PMA Number | P840001 |
Supplement Number | S198 |
Date Received | 11/04/2011 |
Decision Date | 12/12/2011 |
Product Code |
LGW |
Advisory Committee |
Neurology |
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. |