WaveWriter Alpha Spinal Cord Stimulator (SCS) Mixed Systems, M8 Adaptor
FDA premarket approval P030017/S374 · decided 2025-12-18
Approval details
- PMA number
- P030017
- Supplement
- S374
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- WaveWriter Alpha Spinal Cord Stimulator (SCS) Mixed Systems, M8 Adaptor
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Boston Scientific Corp
- Date received
- 2024-04-02
- Decision date
- 2025-12-18
- Days to decision
- 625 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- Approval for 1) labeling updates to the WaveWriter Alpha Spinal Cord Stimulator (SCS) MRI Safety Guidelines to allow for Bl+rms limits to be set as the primary limiting condition for RF power, 2) a labeling update to the MRI Safety Guidelines and Precision Adapter M8 Instructions for Use to add the Medtronic Specify SureScan MRI Leads to the list of leads compatible with the BSN M8 Adapter as part of the WaveWriter Alpha Spinal Cord Stimulator (SCS) Mixed Systems, and 3) the WaveWriter Alpha SCS
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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 |