|
Device | St. Jude Medical Clinician Programmer Application, St. Jude Medical Patient Controller Application, Proclaim XR 5 Implan |
Generic Name | Stimulator, spinal-cord, totally implanted for pain relief |
Applicant | Abbott Medical 6901 Preston Road Plano, TX 75024 |
PMA Number | P010032 |
Supplement Number | S177 |
Date Received | 06/15/2021 |
Decision Date | 07/15/2021 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for labeling updates to include additional clarification language related to magnets within consumer goods and electronic devices. |