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 | St. Jude Medical Infinity DBS System 4CH Lead & 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 | S029 |
Date Received | 09/08/2017 |
Decision Date | 10/04/2017 |
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 lead tip manufacturing process: updating allowable molecular weight of Bionate 75D, replacing the inline dryer, updating the pre-grind diameter of the lead tip, and optimizing the mold. |
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