NEVRO SENZA SPINAL CORD STIMULATION (SCS) SYSTEM
FDA premarket approval P130022/S011 · decided 2017-01-17
Approval details
- PMA number
- P130022
- Supplement
- S011
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NEVRO SENZA SPINAL CORD STIMULATION (SCS) SYSTEM
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Nevro Corporation
- Date received
- 2016-12-19
- Decision date
- 2017-01-17
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Redwood City, CA
- Statement
- Packaging configuration change (i.e., pre-loaded percutaneous lead with the 0.014 curved stylet) to the Senza SCS System.
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