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, Vercise PC, and Vercise Gevia Deep Brain Stimulation (DBS) Systems |
Generic Name | Stimulator, electrical, implanted, for parkinsonian symptoms |
Applicant | Boston Scientific Corp. 25155 Rye Canyon Loop Valencia, CA 91355 |
PMA Number | P150031 |
Supplement Number | S027 |
Date Received | 11/06/2019 |
Decision Date | 12/04/2019 |
Product Code |
NHL |
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 Increase the maximum proximal end backfill cure time from 4 hours to 48 hours for its Leads and Lead Extension for the Vercise, Vercise PC, and Vercise Gevia VNS Systems. |
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