Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | RESTORE, RESTOREPRIME, RESTOREADVANCED, RESTORE PRIME ADVANCED, AND RESTOREULTRA NEUROSTIMULATION 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 | S122 |
Date Received | 10/08/2008 |
Decision Date | 12/08/2008 |
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 |
Approval Order Statement APPROVAL FOR THE ADDITION OF A STABILIZING COIL TO THE MODEL 37083 EXTENSION, A ¿POST-CURE¿ PROCESSING STEP AT THE DISTAL END OF THE MODELS 37083 AND 37082 EXTENSIONS, AND A PROXIMAL BOND STRENGTH (THERMAL BOND) DESIGN REQUIREMENT FOR MODELS 37083 AND 37082 EXTENSIONS. |
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