|
Device | Restore, Itrel and Synergy Spinal Cord Stimulation Systems and Pisces Specify and Vectris Spinal Cord Stimulation Lead |
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 | S361 |
Date Received | 04/28/2017 |
Decision Date | 05/25/2017 |
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 Manufacturing process change to add vapor degreaser cleaning to the build clean process at Medtronic Tempe Campus (MTC). |