|
Device | SCS NEUROSTIMULATOR EXTERNAL/RESTOREPRIME/PRIMEADVANCED/RESTORE/RESTOREULTRA/RESTOREADVANCED/RESTORESENSOR |
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 | S200 |
Date Received | 12/08/2011 |
Decision Date | 12/28/2011 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement UPGRADE AND USE VERSION 6.4 OF THE HYBRID SLANT HANDLER SOFTWARE AT MEDTRONIC¿S HYBRID SUPPLIER. |