VERCISE DEEP BRAIN STIMULATION (DBS)SYSTEM
FDA premarket approval P150031/S085 · decided 2025-05-29
Approval details
- PMA number
- P150031
- Supplement
- S085
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- VERCISE DEEP BRAIN STIMULATION (DBS)SYSTEM
- Generic name
- Stimulator, electrical, implanted, for parkinsonian symptoms
- Applicant
- Boston Scientific Corp
- Date received
- 2025-05-02
- Decision date
- 2025-05-29
- Days to decision
- 27 days
- Decision code
- APPR
- Product code
- NHL
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- Approval for 1. Change to Item 6, Figure 21 to an image with a floating clip2. Added to Item 7, New Figure 22 with an extended lead (Figure 22. Push the Retaining Clip Into the Base)3. Added to Item 8: a. Note: If you have difficulty locking the Slider, you may need to remove the Lead Stylet before locking the Slider in place, or replace the Retaining Clip using another Burr Hole Cover Kit or Burr Hole Cover Spares Kit.b. Added New Figure 23 to include Lead and Screws (Figure 23. Lock the Slid
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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 |