|
Device | RESTORE ULTRA NEUROSTIMULATOR, RESTORE SENSOR NEUROSTIMULATOR, ITREL 4 NEUROSTIMULATOR AND ENTERNAL 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 | S234 |
Date Received | 02/07/2013 |
Decision Date | 06/19/2013 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR FIRMWARE CHANGES INTENDED TO CORRECT DEVICE BEHAVIORS THAT RESULT IN TEMPORARY LOSS OF STIMULATION (EXCEPTION BIT) AND CAN AFFECT PROGRAMMED STIMULATION PARAMETERS (OVER-DISCHARGE). |