|
Device | ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS |
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 | S348 |
Date Received | 11/23/2016 |
Decision Date | 12/22/2016 |
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 New supplier of several stylet component families and an associated minor manufacturing process, material and drawing changes. |