|
Device | SOLETRA/KINETRA/EXTERNAL/ACTIVA FAMILY OF NEUROSTIMULATORS |
Generic Name | Stimulator, electrical, implanted, for parkinsonian tremor |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P960009 |
Supplement Number | S100 |
Date Received | 10/25/2010 |
Decision Date | 11/24/2010 |
Product Code |
MHY |
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. |