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Device | ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P960009 |
Supplement Number | S222 |
Date Received | 03/06/2015 |
Decision Date | 04/02/2015 |
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 ADDITION OF AN ADDITIONAL SUPPLIER FOR THE GOLD PREFORMS AND TO INCORPORATE THE USE OF AN ELECTRONIC TRACKING SYSTEM. |