Vercise PC DBS System, Vercise Gervia DBS System, Vercise Genus DBS System
FDA premarket approval P150031/S064 · decided 2024-02-29
Approval details
- PMA number
- P150031
- Supplement
- S064
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Vercise PC DBS System, Vercise Gervia DBS System, Vercise Genus DBS System
- Generic name
- Stimulator, electrical, implanted, for parkinsonian symptoms
- Applicant
- Boston Scientific Corp
- Date received
- 2023-09-29
- Decision date
- 2024-02-29
- Days to decision
- 153 days
- Decision code
- APPR
- Product code
- NHL
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- Expanding the current indications for use (IFU) to include Bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the suppression of disabling upper extremity tremor in adult essential tremor patients whose tremor is not adequately controlled by medications and where the tremor constitutes a significant functional disability
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330) (K243245) | Boston Scientific Corp | 2024-10-18 |
| LUX-Dx II (M302); LUX-Dx II+ (M312) (K231328) | Boston Scientific Corp | 2023-08-19 |
| WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary (K152853) | Boston Scientific Corp | 2015-11-20 |
| AXIOS Stent with Electrocautery Enhanced Delivery System (K150692) | Boston Scientific Corp | 2015-08-05 |
| XXL Vascular Balloon Dilatation Catheter (K150303) | Boston Scientific Corp | 2015-06-15 |
| Chariot Guiding Sheath (K150186) | Boston Scientific Corp | 2015-06-05 |
| EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector (K150679) | Boston Scientific Corp | 2015-05-29 |
| JAGWIRE HIGH PERFORMANCE GUIDWIRE (K141820) | Boston Scientific Corp | 2014-10-21 |