|
Device | Spinal Cord Stimulation (SCS) System |
Generic Name | Stimulator, spinal-cord, totally implanted for pain relief |
Applicant | Abbott Medical 6901 Preston Road Plano, TX 75024 |
PMA Number | P010032 |
Supplement Number | S180 |
Date Received | 09/27/2021 |
Decision Date | 12/30/2021 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval to add Midwest Sterilization Corporation located at 1204 Lenco Ave. Jackson, Mo 63755 as an alternate ethylene oxide (EO) sterility facility. |