|
Device | MEDTRONIC SPINAL CORD STIMULATION SYSTEM |
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 | S059 |
Date Received | 11/13/2001 |
Decision Date | 12/11/2001 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE TO THE MANUFACTURING PROCESS TO INCLUDE AN ADDITIONAL METHOD FOR MONITORING ETHYLENE GAS CONCENTRATIONS DURING THE STERILIZATION PROCESS. |