Senza Spinal Cord Stimulation (SCS) System
FDA premarket approval P130022/S017 · decided 2018-03-19
Approval details
- PMA number
- P130022
- Supplement
- S017
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Senza Spinal Cord Stimulation (SCS) System
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Nevro Corporation
- Date received
- 2017-09-12
- Decision date
- 2018-03-19
- Days to decision
- 188 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Redwood City, CA
- Statement
- Approval for a manufacturing site located at Pro-Tech Design & Mfg, Inc., 13719 Borate St, Santa Fe Springs, California.
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