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Trade Name | Activa® Dystonia Therapy System, SenSight™ Extension Kit |
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 |
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HDE Number | H020007 |
Supplement Number | S303 |
Date Received | 09/27/2021 |
Decision Date | 10/27/2021 |
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 for changes to the proximal body assembly (pba), which includes increasing the pba core pin outer diameter tolerance and allowing replacement of pba tensile test samples when there is a tubing break below the required acceptance criteria, for the sensight directional lead system (octave) extension subassemblies at the medtronic danvers, ma facility. |