Precision Spectra / Novi / Wavewriter Spinal Cord Stimulator (SCS) System, Precision Montage Spinal Cord Stimulator (SCS
FDA premarket approval P030017/S298 · decided 2017-07-12
Approval details
- PMA number
- P030017
- Supplement
- S298
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Precision Spectra / Novi / Wavewriter Spinal Cord Stimulator (SCS) System, Precision Montage Spinal Cord Stimulator (SCS
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Boston Scientific Corp
- Date received
- 2017-06-13
- Decision date
- 2017-07-12
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- Adding an alternate qualified supplier and post-curing process for the core seals used in the assembly to the Precision Spectra WaveWriter Implantable Pulse Generator (IPG).
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510(k) clearances by this applicant
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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 |