Premarket Approval (PMA)

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.

• Device: Activa Deep Brain Stimulation Therapy System and Percept PC Deep Brain Stimulation Therapy System
• Generic Name: Stimulator, electrical, implanted, for parkinsonian tremor
• Applicant: Medtronic, Inc.; 7000 Central Ave., NE; Minneapolis, MN 55432
• PMA Number: P960009
• Supplement Number: S383
• Date Received: 09/02/2020
• Decision Date: 10/28/2020
• Product Code: MHY
• Advisory Committee: Neurology
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval of the revised protocol for the post-approval study (PAS) protocol.