|
Device | ITREL 3 IMPLANTABLE/SYNERGY FAMILY OF IMPLANTABLE NEUROSTIMULATORS/EXTERNAL NEUROSTIMULATORS |
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 | S168 |
Date Received | 10/25/2010 |
Decision Date | 11/24/2010 |
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 | Yes |
Approval Order Statement IMPLEMENTATION OF UPDATED HARDWARE AND SOFTWARE FOR THE BARCODE/OPTICAL CHARACTER RECOGNITION LABELER SYSTEM AS WELL AS A PROCESS CHANGE PERTAINING TO THE UPGRADED LABELER SYSTEM. |