|
Device | DBS System 4CH Lead / DBS System 8CH Directional Lead |
Generic Name | Stimulator, electrical, implanted, for parkinsonian tremor |
Applicant | Abbott Medical 6901 Prestion Road Plano, TX 75024 |
PMA Number | P140009 |
Supplement Number | S036 |
Date Received | 02/02/2018 |
Decision Date | 08/10/2018 |
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 Approval for updating the primer application step of the parylene coating of the stim tips and term tips from vapor deposition to dipping application. |