| Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the Original HDE to get an up-to-date view of this device. |
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| Trade Name | Activa Dystonia Therapy System, Percept PC BrainSense |
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| Classification Name | implanted subcortical electrical stimulator (motor disorders) |
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| Generic Name | implanted subcortical electrical stimulator (motor disorders) |
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| Applicant |
| MEDTRONIC NEUROMODULATION |
| 7000 central avenue ne |
| rcw 225 |
| minneapolis, MN 55432 |
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| HDE Number | H020007 |
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| Supplement Number | S299 |
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| Date Received | 08/03/2021 |
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| Decision Date | 09/01/2021 |
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| Product Code | |
| Advisory Committee |
Neurology |
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| Supplement Type | 30-day notice |
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| Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order Statement
Approval for 1) equipment updates in the cea 2-3 silicone molding area (e. G. , six additional ovens), updated option for use of temperature recorder (vaisala monitoring system model vl-1700-54t), updated oven mode for the new ovens to use manual mode, removal of monitor lot for all ovens, removal of setup lot of new ovens, addition of a new and smaller basket for oven use, and addition of a new toolmaker scope (nikon mm-40), 2) an update to the applicable work instructions (wi), and 3) the oven operation of allowing the new ovens to be opened during the middle of a run to add or remove lots from the oven and factoryworks (fw) updates to support the changes. |
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