|
Device | Vercise 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 | S022 |
Date Received | 08/05/2019 |
Decision Date | 09/04/2019 |
Product Code |
NHL |
Advisory Committee |
Neurology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of the Changes Being Effected (CBE) for the Vercise Deep Brain Stimulation (DBS) Systems. The changes being effected include changes to Vercise Deep Brain Stimulation (DBS) Systems physician and patient labeling, to enhance and harmonize the information regarding the risks of depression, suicide ideation, and suicide across the device type. |