|
Device | ITREL 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 | S044 |
Date Received | 01/18/2000 |
Decision Date | 03/21/2000 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | Real-Time Process |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for device and manufacturing process changes to the existing Model 7424 ITREL II Neurostimulator, for use in conjunction with the Medtronic Itrel Spinal Cord Stimulation System. |