|
Device | Spinal Cord Stimulation (SCS) Legacy Charger Systems and Accessories |
Generic Name | Stimulator, spinal-cord, totally implanted for pain relief |
Applicant | Abbott Medical 6901 Preston Road Plano, TX 75024 |
PMA Number | P010032 |
Supplement Number | S207 |
Date Received | 09/29/2023 |
Decision Date | 10/27/2023 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement approval for a proposed alternate electromagnetic interference (EMI)/ radiofrequency interference (RFI) shield coating component used in the production of Abbott Neuromodulation (NMD) legacy chargers |