|
Device | RESTORE FAMILY OF NEUROSTIMULATOR SYSTEMS |
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 | S113 |
Date Received | 05/16/2008 |
Decision Date | 06/10/2008 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement ADD A NEW COMPONENT VENDOR TO SUPPLY TWO INTEGRATED CIRCUITS (ICS) FOR USE ON THE HYBRIDS IN THE RESTORE FAMILY OF DEVICES. |