|
Device | Proclaim family of SCS IPGs |
Generic Name | Stimulator, spinal-cord, totally implanted for pain relief |
Applicant | Abbott Medical 6901 Preston Road Plano, TX 75024 |
PMA Number | P010032 |
Supplement Number | S149 |
Date Received | 03/21/2019 |
Decision Date | 09/17/2019 |
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 updating the Clinician Programmer Application and Patient Controller Application to support an expanded allowable impedance range for MR Conditional devices entering MRI Mode, and to amend your labeling and software to change the term Program Mode to Dosage and Cycle to Intermittent. |