|
Device | Proclaim SCS Neurostimulation System FW |
Generic Name | Stimulator, spinal-cord, totally implanted for pain relief |
Applicant | Abbott Medical 6901 Preston Road Plano, TX 75024 |
PMA Number | P010032 |
Supplement Number | S148 |
Date Received | 01/23/2019 |
Decision Date | 05/03/2019 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for an update to the firmware version to v1.3 for the legally marketed family Proclaim Spinal Cord Stimulation (SCS) Implantable Pulse Generators. |