|
Device | RESTORE FAMILY OF NEUROSTIMULATION DEVICES |
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 | S136 |
Date Received | 04/09/2009 |
Decision Date | 06/08/2009 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | Real-Time Process |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MINOR MODIFICATIONS TO THE TORQUE WRENCH AND STYLET ACCESSORIES. |