Precision Spectra, Spectra WaveWriter, Precision Montage, and Precision Montage MRI Spinal Cord Stimulatort (SCS) System
FDA premarket approval P030017/S316 · decided 2018-08-01
Approval details
- PMA number
- P030017
- Supplement
- S316
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Precision Spectra, Spectra WaveWriter, Precision Montage, and Precision Montage MRI Spinal Cord Stimulatort (SCS) System
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Boston Scientific Corp
- Date received
- 2018-07-03
- Decision date
- 2018-08-01
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- Addition of an alternate qualified supplier (TIMET) for the raw material (Grade-23 ELI Titanium) that is used by Heraeus Medical when manufacturing the Case Half and Back-up Band for the Precision Spectra, Spectra WaveWriter, Precision Montage, and Precision Montage MRI implantable pulse generators (IPGs).
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