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 | Percept™ RC BrainSense™ |
Generic Name | Stimulator, electrical, implanted, for parkinsonian tremor |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P960009 |
Supplement Number | S472 |
Date Received | 02/15/2024 |
Decision Date | 04/11/2024 |
Product Code |
MHY |
Advisory Committee |
Neurology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Minor design and manufacturing changes to metal strip resistors, Specifically, 1) Change in construction from a copper clad technology to a welded copper technology; 2) Change in resistor height requirement; and 3) Change in supplier resistor manufacturing facility from Columbus, NE to the Be’er Sheva, Israel. |
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