Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPGs), leads, extensions, and accessories |
Generic Name | Stimulator, electrical, implanted, for parkinsonian tremor |
Applicant | Abbott Medical 6901 Prestion Road Plano, TX 75024 |
PMA Number | P140009 |
Supplement Number | S089 |
Date Received | 09/01/2023 |
Decision Date | 09/29/2023 |
Product Codes |
MHY NHL PJS |
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 Improvements to the quality control testing that is performed on finished device software applications to ensure that they continue to operate as intended on new mobile platforms or iOS versions. |
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