|
Device | Activa Deep Brain Stimulation Therapy Systems |
Generic Name | Stimulator, electrical, implanted, for parkinsonian tremor |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P960009 |
Supplement Number | S378 |
Date Received | 08/04/2020 |
Decision Date | 08/12/2020 |
Product Code |
MHY |
Advisory Committee |
Neurology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of Changes being Effected (CBE) for the enhancement and harmonization of the physician and patient labeling to include precaution statements regarding risks of loss of coordination during activities requiring coordination (e.g. swimming) and bathing in the labeling across the device type. |