|
Device | RESTORE FAMILY/ITREL3 FAMILY/SYNERGY FAMILY OF IMPLANTABLE NEUROSTIMULATORS/SPECIFY SURGICAL LEADS/HINGED 2X4 SURGICAL |
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 | S172 |
Date Received | 12/07/2010 |
Decision Date | 01/05/2011 |
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 UPGRADE OF SOFTWARE USED FOR STATISTICAL PROCESS CONTROL AND ANALYSIS OF INSPECTION DATA. |