PRECISION SPECTRA SPINAL STIMULATOR (SCS) SYSTEM
FDA premarket approval P030017/S186 · decided 2014-05-22
Approval details
- PMA number
- P030017
- Supplement
- S186
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PRECISION SPECTRA SPINAL STIMULATOR (SCS) SYSTEM
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Boston Scientific Corp
- Date received
- 2013-12-16
- Decision date
- 2014-05-22
- Days to decision
- 157 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- APPROVAL FOR DESIGN CHANGES TO PRECISION SPECTRA OR CABLE AND EXTENSION AND AN ALTERNATE QUALIFIED SUPPLIER (ONANON INC. MILPITAS, CA).
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