|
Device | Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) |
Generic Name | Stimulator, spinal-cord, totally implanted for pain relief |
Applicant | Abbott Medical 6901 Preston Road Plano, TX 75024 |
PMA Number | P010032 |
Supplement Number | S212 |
Date Received | 03/07/2024 |
Decision Date | 04/05/2024 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement revert manufacturing of IPG boards for SCS, DRG and DBS to original C68 component |