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 TREMOR CONTROL 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 | S009 |
Date Received | 01/18/2000 |
Decision Date | 03/21/2000 |
Product Code |
MHY |
Advisory Committee |
Neurology |
Supplement Type | Real-Time Process |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for device and manufacturing process changes to the existing Model 7424 ITREL II Neurostimulator, and rebranding of this device under the new tradename, Soletra Model 7426 Neurostimulator, for use in conjunction with the existing Medtronic Activa Tremor Control System. |
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