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Trade Name | Percept 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 |
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HDE Number | H020007 |
Supplement Number | S288 |
Date Received | 12/18/2020 |
Decision Date | 01/15/2021 |
Product Code | |
Advisory Committee |
Neurology |
Supplement Type | special (immediate track) |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement The center for devices and radiological health (cdrh) of the food and drug administration (fda) has completed its review of your premarket approval application (pma) supplement, which requested approval for use of a screening tool to screen/filter out a list of invalid hybrid serial numbers from the next available 1,048,564 serial numbers. The resulting invalid hybrid serial numbers are to be programmed into your factoryworks table to prevent them from being used for future hybrid manufacturing builds. |