Precision Spectra Spinal Cord Stimulator (SCS) System, Precision Novi Spinal Cord Stimulator (SCS) System, Precision Mon
FDA premarket approval P030017/S344 · decided 2021-07-12
Approval details
- PMA number
- P030017
- Supplement
- S344
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Precision Spectra Spinal Cord Stimulator (SCS) System, Precision Novi Spinal Cord Stimulator (SCS) System, Precision Mon
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Boston Scientific Corp
- Date received
- 2021-04-19
- Decision date
- 2021-07-12
- Days to decision
- 84 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- Approval for an update to the existing Software Bionic Navigator 3D version 4.0 to version 4.1. The updated software will be installed on the Clinician Programmer using the Bionic Navigator (BN) 3D 4.1 Installer (Model # SC-7101-410). This would allow one single software version (BN3D 4.1) to support all the Precision Spectra, Precision Novi, Precision Montage MRI, and Spectra WaveWriter and WaveWriter Alpha BCS Stimulators. The user interface of BN 3D 4.1 remain the same except for translations
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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 |