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 | Vercise Genus™ DBS Systems, Vercise Gevia™ DBS System, Vercise™ PC DBS System |
Generic Name | Stimulator, electrical, implanted, for parkinsonian symptoms |
Applicant | Boston Scientific Corp. 25155 Rye Canyon Loop Valencia, CA 91355 |
PMA Number | P150031 |
Supplement Number | S060 |
Date Received | 08/30/2023 |
Decision Date | 10/10/2023 |
Product Code |
NHL |
Advisory Committee |
Neurology |
Supplement Type | Real-Time Process |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement approval for change of Tungsten Stylet supplier, change of stylet handle design, and change of source for Polytetrafluoroethylene coating. |
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