|
Device | RESTORE ULTRA IMPLANTABLE NEUROSTIMULATOR |
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 | S163 |
Date Received | 08/17/2010 |
Decision Date | 09/16/2010 |
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 UPDATE OF THE SOFTWARE FOR THE LASER RIBBON BONDING (ORB) PROCESSING EQUIPMENT LOCATED AT MEDTRONIC¿S PUERTO RICO OPERATIONS COMPANY (MPROC) IN JUNCOS, PUERTO RICO. |