Precision Spinal Cord Stimulator (SCS) System- (Precision Spectra, Spectra WaveWriter, Precision Novi, Precision Montage
FDA premarket approval P030017/S330 · decided 2019-09-24
Approval details
- PMA number
- P030017
- Supplement
- S330
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Precision Spinal Cord Stimulator (SCS) System- (Precision Spectra, Spectra WaveWriter, Precision Novi, Precision Montage
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Boston Scientific Corp
- Date received
- 2019-08-26
- Decision date
- 2019-09-24
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- Statistical Process Monitoring and Control (SPC)-based sampling plan to be used for in-process monitoring of validated processes at the Boston Scientific Neuromodulation (BSN) manufacturing sites.
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510(k) clearances by this applicant
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|---|---|---|
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| 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 |
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| 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 |