Vercise Genus Deep Brain Stimulation (DBS) System
FDA premarket approval P150031/S066 · decided 2024-01-10
Approval details
- PMA number
- P150031
- Supplement
- S066
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Vercise Genus Deep Brain Stimulation (DBS) System
- Generic name
- Stimulator, electrical, implanted, for parkinsonian symptoms
- Applicant
- Boston Scientific Corp
- Date received
- 2023-10-26
- Decision date
- 2024-01-10
- Days to decision
- 76 days
- Decision code
- APPR
- Product code
- NHL
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- approval for MR Conditional status of the following three configurations for use with two Boston Scientific Vercise Genus Implanted Pulse Generators (IPG): Boston Scientific Leads, One IPG with Boston Scientific Lead and One IPG with Medtronic Lead (with M8 Lead Adapter), and Medtronic Leads (with M8 Lead Adapters)
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 |