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 Gevia DBS System and Directional Lead-only 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 | S011 |
Date Received | 01/31/2019 |
Decision Date | 08/19/2019 |
Product Code |
NHL |
Advisory Committee |
Neurology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for MR Conditional labeling of the Vercise Gevia Deep Brain Stimulation (DBS) System. |
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