|
Device | Genesis Neurostimulation 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 | S181 |
Date Received | 10/01/2021 |
Decision Date | 11/03/2021 |
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 Consolidate the Electrical testing at the cleaning step and QC inspection step of the manufacturing process and for the consolidated step to be performed after the Weld tip/Leak test step using automated CAMI lead test system in the Abbott Medical Puerto Rico, LLC manufacturing site. |