|
Device | ACTIVA DEEP BRIAN STIMULATION THERAPY SYSTEM |
Generic Name | Stimulator, electrical, implanted, for parkinsonian tremor |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P960009 |
Supplement Number | S249 |
Date Received | 04/05/2016 |
Decision Date | 05/05/2016 |
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 | No |
Approval Order Statement Relocation of the parts cleaning of the impacted piece parts (components) from the Medtronic Sullivan Lake (SL) facility to the Medtronic Rice Creek (RC) facility. |