|
Trade Name | ACTIVA DYSTONIA THERAPY SYSTEM |
Classification Name | implanted subcortical electrical stimulator (motor disorders) |
Generic Name | implanted subcortical electrical stimulator (motor disorders) |
Applicant |
MEDTRONIC NEUROMODULATION |
7000 central avenue ne |
rcw 225 |
minneapolis, MN 55432 |
|
HDE Number | H020007 |
Supplement Number | S150 |
Date Received | 11/23/2015 |
Decision Date | 12/23/2015 |
Product Code | |
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 Update of the pull test sample size and control limits used for special manufacturing process monitoring in alignment with the statistical process control program at medtronic puerto rico operations company in villalba, puerto rico. |