|
Device | RESTORE FAMILY OF NEUROSTIMULATORS |
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 | S159 |
Date Received | 08/02/2010 |
Decision Date | 04/22/2011 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR MINOR DESIGN CHANGES TO THE L283 MULTI-FUNCTION INTEGRATED CIRCUIT CONTAINED IN THE NEUROSTIMULATORS OF THE DEVICE. |