SENZA SPINAL CORD STIMULATION (SCS) SYSTEM
FDA premarket approval P130022/S004 · decided 2016-04-15
Approval details
- PMA number
- P130022
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- 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
- 2015-11-23
- Decision date
- 2016-04-15
- Days to decision
- 144 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Redwood City, CA
- Statement
- Approval for the Surgical Lead Models LEAD3005-xx, LEAD3015-xx, and LEAD3025-xx.
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