Senza Spiral Cord Stimulation (SCS) System
FDA premarket approval P130022/S062 · decided 2024-12-03
Approval details
- PMA number
- P130022
- Supplement
- S062
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Senza Spiral Cord Stimulation (SCS) System
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Nevro Corporation
- Date received
- 2024-11-07
- Decision date
- 2024-12-03
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Redwood City, CA
- Statement
- the addition of Zollner as the printed circuit board assembly (PCBA) supplier for the Programmer Wand (CLPW1000)
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