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 Generator (IPG) |
Generic Name | Stimulator, electrical, implanted, for parkinsonian tremor |
Applicant | Abbott Medical 6901 Prestion Road Plano, TX 75024 |
PMA Number | P140009 |
Supplement Number | S080 |
Date Received | 09/29/2022 |
Decision Date | 10/28/2022 |
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 Implement two manufacturing changes used in the production of contact assemblies in supplier Bal Seal Engineering, Inc.’s production of contact assemblies, i.e., 1) to qualify alternate welding equipment used to process the spring component of contact assemblies; and 2) to implement visual automated optical inspection for performing the 100% inspection of the spring component's inner diameter. |
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