|
Device | Restore and Itrel® Spinal Cord Stimulation Systems |
Generic Name | Stimulator, spinal-cord, totally implanted for pain relief |
Applicant | MEDTRONIC NEUROMODULATION 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432 |
PMA Number | P840001 |
Supplement Number | S536 |
Date Received | 01/20/2023 |
Decision Date | 02/02/2023 |
Product Code |
LGW |
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 Implement manufacturing process changes at an external supplier in order to manufacturing different sized TBC series tantalum capacitors. |