PRECISION SPECTRA SYSTEM
FDA premarket approval P030017/S201 · decided 2014-08-28
Approval details
- PMA number
- P030017
- Supplement
- S201
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PRECISION SPECTRA SYSTEM
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Boston Scientific Corp
- Date received
- 2014-06-02
- Decision date
- 2014-08-28
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- APPROVAL FOR A CHANGE TO THE PRECISION SPECTRA OBSERVATIONALMECHANICAL GATEWAY (OMG) DIRECTIONS FOR USE. THE PROPOSED CHANGE IS TO ADD THE ST JUDE PENTA LEAD (MODEL # 3228) TO THE TABLE OF COMPATIBLE ST. JUDE LEADS IN THE DIRECTIONS FOR USE. IN ADDITION, A STATEMENT WAS ADDED TO THE INTENDED USE SECTION TO REFER TO THE PRECISION SPECTRA SYSTEM MANUALS FOR THE INDICATIONS AND CONTRAINDICATIONS.
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