|
Trade Name | Percept™ RC BrainSense™ |
Classification Name | implanted subcortical electrical stimulator (motor disorders) |
Generic Name | implanted subcortical electrical stimulator (motor disorders) |
Applicant |
MEDTRONIC NEUROMODULATION |
7000 central avenue ne |
rcw 225 |
minneapolis, MN 55432 |
|
HDE Number | H020007 |
Supplement Number | S362 |
Date Received | 02/15/2024 |
Decision Date | 04/11/2024 |
Product Code | |
Advisory Committee |
Neurology |
Supplement Type | normal 75 day track |
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. |