|
Device | MEDTRONIC RESTORE FAMILY IMPLANTABLE 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 | S100 |
Date Received | 10/05/2007 |
Decision Date | 02/29/2008 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A NEW COMPONENT VENDOR FOR TWO INTEGRATED CIRCUITS (ICS) USED ON THE HYBRID IN THE RESTORE FAMILY OF DEVICES. |