|
Device | St, Jude Medical Infinity Deep Brain Stimulation (DBS) Leads |
Generic Name | Stimulator, electrical, implanted, for parkinsonian tremor |
Applicant | Abbott Medical 6901 Prestion Road Plano, TX 75024 |
PMA Number | P140009 |
Supplement Number | S041 |
Date Received | 10/18/2018 |
Decision Date | 11/14/2018 |
Product Codes |
MHY NHL PJS |
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 Approval to add X-ray inspections during the manufacture of the electrode subassemblies to enhance the safety of the leads for the Infinity Deep Brain Stimulation System. |