|
Device | ACTIVA THERAPY FOR DBS |
Generic Name | Stimulator, electrical, implanted, for parkinsonian tremor |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P960009 |
Supplement Number | S055 |
Date Received | 07/24/2008 |
Decision Date | 10/17/2008 |
Product Code |
MHY |
Advisory Committee |
Neurology |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE IMPLEMENTATION OF THE STERILIZATION AUTOMATED RELEASE OR STAR SYSTEM TO THE STERILIZATION OPERATION AT THE MEDTRONIC NEUROMODULATION SULLIVAN LAKE MANUFACTURING FACILITY. |