|
Device | DBS System - Lead and Extension |
Generic Name | Stimulator, electrical, implanted, for parkinsonian tremor |
Applicant | Abbott Medical 6901 Prestion Road Plano, TX 75024 |
PMA Number | P140009 |
Supplement Number | S084 |
Date Received | 06/23/2023 |
Decision Date | 02/21/2024 |
Product Codes |
MHY NHL PJS |
Advisory Committee |
Neurology |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement The firm requested approval to qualify a new manufacturing site and process improvements for an existing supplier of materials used in the manufacture of DBS Leads and Extensions and to utilize a new supplier for components used in the manufacture of the DBS Extensions. Based upon the information submitted, the PMA supplement is approved. |