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 | 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 | S091 |
Date Received | 01/05/2024 |
Decision Date | 02/02/2024 |
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 to relocate the SCS Leads and DBS Infinity Leads packaging operations from an ISO Class 7 clean access environment to In-line Packaging in an ISO Class 8 clean access environment at your Plano, Texas manufacturing facility |
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