Senza Spinal Cord Stimulation (SCS) System
FDA premarket approval P130022/S043 · decided 2022-09-30
Approval details
- PMA number
- P130022
- Supplement
- S043
- 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
- 2021-11-17
- Decision date
- 2022-09-30
- Days to decision
- 317 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 Nevro Medical S.R.L. Building 28-C, Coyol Free Zone Park C.R. El Coyol, Alajuela Costa Rica, 20101 to manufacture IPG, charger and patient remotes.
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