|
Device | PROTEGE MRI NEUROSTIMULATION SYSTEM |
Generic Name | Stimulator, spinal-cord, totally implanted for pain relief |
Applicant | Abbott Medical 6901 Preston Road Plano, TX 75024 |
PMA Number | P010032 |
Supplement Number | S085 |
Date Received | 09/29/2014 |
Decision Date | 04/22/2015 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE PROTEGE MRI IPG MODEL 3 771 AND PATIENT PROGRAMMER (PPGR) MODEL 3853 WHICH HAVE UPDATED LABELING THAT WILL ALLOW PATIENTS TO UNDERGO MRI SCANS OF THE HEAD AND EXTREMITIES PER THE DEFINED CONDITIONS. |