Nevro Corp Senza Spinal Cord Stimulation (SCS) System
FDA premarket approval P130022/S029 · decided 2021-06-09
Approval details
- PMA number
- P130022
- Supplement
- S029
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Nevro Corp Senza Spinal Cord Stimulation (SCS) System
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Nevro Corporation
- Date received
- 2019-10-15
- Decision date
- 2021-06-09
- Days to decision
- 603 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Redwood City, CA
- Statement
- Approval for addition of an alternate supplier of the Hysol epoxy materials used to make the header component of the implantable pulse generator (IPG) of the Senza neuromodulation system
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