| Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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| Device | Activa Deep Brain Stimulation Therapy System |
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| Generic Name | Stimulator, electrical, implanted, for parkinsonian tremor |
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| Applicant | MEDTRONIC Inc.
7000 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432-3576 |
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| PMA Number | P960009 |
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| Supplement Number | S297 |
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| Date Received | 09/20/2017 |
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| Decision Date | 10/20/2017 |
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| Product Code |
MHY |
| Advisory Committee |
Neurology |
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| Supplement Type | Special (Immediate Track) |
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| Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order Statement
Approval for the addition of new safety information (tunneling procedure unintended nerve tissue injury warning and adverse event, loss of coordination precaution, weight gain/loss adverse event) and safety enhancement clarifications (update guidance on avoiding damage to the neurostimulator (Physician Labeling), clarify text that accompanies the figure for accurate right and left hemisphere lead-extension connection when placing dual lead systems (Physician Labeling), remove incorrect length of the DBS lead placed under the scalp (Patient Labeling)). |
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