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 |
Generic Name | Stimulator, electrical, implanted, for parkinsonian tremor |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P960009 |
Supplement Number | S329 |
Date Received | 10/30/2018 |
Decision Date | 11/08/2018 |
Product Code |
MHY |
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 Consolidate the laser weld pull strength monitoring tests for four model families into one group (affected models: 977A160, 977A175, 977A190, 977A260, 977A275, 977A290, 977D160, 977D260, 3776, 3777, 3778, 37081, 37082, 37083, 37085, 37086). |
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