WaveWriter Alpha Prime Spinal Cord Stimulation (SCS) Systems
FDA premarket approval P030017/S389 · decided 2025-12-10
Approval details
- PMA number
- P030017
- Supplement
- S389
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- WaveWriter Alpha Prime Spinal Cord Stimulation (SCS) Systems
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Boston Scientific Corp
- Date received
- 2025-09-25
- Decision date
- 2025-12-10
- Days to decision
- 76 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- approval for the extension of shelf-life from 6 months to 15 months for the Hydrogen Silsesquioxane material utilized in the insulation layer production of a component within the printed circuit board assembly of Implantable Pulse Generator (IPG) and of External Trial Stimulator (ETS) Kits in the WaveWriter Alpha Prime Spinal Cord Stimulation and Vercise Genus Deep Brain Stimulation Systems. The component, manufactured by a third-party supplier, is not patient-contacting and is fully encapsula
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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 |