Vercise PC, Vercise Gevia, Vercise Genus Deep Brain Stimlation (DBS) Systems
FDA premarket approval P150031/S061 · decided 2023-09-27
Approval details
- PMA number
- P150031
- Supplement
- S061
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Vercise PC, Vercise Gevia, Vercise Genus Deep Brain Stimlation (DBS) Systems
- Generic name
- Stimulator, electrical, implanted, for parkinsonian symptoms
- Applicant
- Boston Scientific Corp
- Date received
- 2023-08-31
- Decision date
- 2023-09-27
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- NHL
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- Alternate packaging supplier for an Inner Tray packaging component used to package Spinal Cord Stimulator and Deep Brain Stimulator Lead Products (Extensions, Splitters, Adapters, and Connectors) at the Boston Scientific Dorado Puerto Rico manufacturing site.
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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 |