Vercise Genus DBS System, Vercise Gevia DBS System, Vercise PC DBS System
FDA premarket approval P150031/S065 · decided 2024-11-13
Approval details
- PMA number
- P150031
- Supplement
- S065
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Vercise Genus DBS System, Vercise Gevia DBS System, Vercise PC DBS System
- Generic name
- Stimulator, electrical, implanted, for parkinsonian symptoms
- Applicant
- Boston Scientific Corp
- Date received
- 2023-09-29
- Decision date
- 2024-11-13
- Days to decision
- 411 days
- Decision code
- APPR
- Product code
- NHL
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- which requested approval for the following: Vercise Cartesia X Directional Lead Kits (Models DB-2203-30B and DB-2203-45B), Vercise Cartesia HX 16-contact Directional Lead Kits (Models DB-2204-30B and DB-2204-45B), 16-contact Lead Extension Kits (Models DB-3216-55 and DB-3216-95), 2x8 Lead Extension Kits (Models DB-3128 and DB-3128-95), and Vercise Physicians Spare Kit (Model DB-2501).
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |