Senza Spinal Cord Stimulation (SCS) System
FDA premarket approval P130022/S037 · decided 2021-03-01
Approval details
- PMA number
- P130022
- Supplement
- S037
- 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
- 2020-09-30
- Decision date
- 2021-03-01
- Days to decision
- 152 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Redwood City, CA
- Statement
- Approval for addition of OSCOR Caribe located at Santo Domingo Este, Dominican Republic as a secondary manufacturing site for the Percutaneous Leads of the Senza neuromodulation system. Pro-Tech Design & Manufacturing Inc. and Steris-Isomedix Services will continue to perform final packaging and sterilization, respectively.
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