Vercise Genus DBS System
FDA premarket approval P150031/S045 · decided 2022-03-24
Approval details
- PMA number
- P150031
- Supplement
- S045
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Vercise Genus DBS System
- Generic name
- Stimulator, electrical, implanted, for parkinsonian symptoms
- Applicant
- Boston Scientific Corp
- Date received
- 2021-09-29
- Decision date
- 2022-03-24
- Days to decision
- 176 days
- Decision code
- APPR
- Product code
- NHL
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- Approval to labeling change to add the Medtronic Leads, Extensions, Lead Accessories and the BSN M8 Adaptor to the list of devices that are Magnetic resonance imaging (MRI) scan eligible for the Vercise Genus DBS System. There is no change to the MRI radiology conditions of use or any other implant conditions of use compared to those approved for the Vercise Genus DBS System.
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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 |