|
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 | S294 |
Date Received | 05/28/2021 |
Decision Date | 06/25/2021 |
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 Approval to the newly defined and characterized solder paste inspection (spi) process at medtronic tempe campus (mtc), medtronic’s internal supplier of hybrids used in the manufacturing of medtronic neuromodulation (neuro) products. |