Senza Spinal Cord Stimulation (SCS) System
FDA premarket approval P130022/S028 · decided 2020-04-25
Approval details
- PMA number
- P130022
- Supplement
- S028
- 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
- 2019-08-12
- Decision date
- 2020-04-25
- Days to decision
- 257 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Redwood City, CA
- Statement
- Approval for use of alternate proposed Integer battery (M3580) on Senza Implantable Pulse Generator, model IPG2000 (Senza II) of Nevro's Senza Spinal Cord Stimulator (SCS) System and associated firmware updates.
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