SENZA SPINAL CORD STIMULATION (SCS) SYSTEM
FDA premarket approval P130022/S002 · decided 2015-12-02
Approval details
- PMA number
- P130022
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SENZA SPINAL CORD STIMULATION (SCS) SYSTEM
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Nevro Corporation
- Date received
- 2015-09-04
- Decision date
- 2015-12-02
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Redwood City, CA
- Statement
- APPROVAL FOR MINOR CHANGES IN THE SENZA SYSTEM IMPLANTABLE PULSE GENERATOR (IPG) AND TRIAL STIMULATION (TSM) FIRMWARE.
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