SENZA SPINAL CORD STIMULATION (SCS) SYSTEM
FDA premarket approval P130022/S007 · decided 2016-11-18
Approval details
- PMA number
- P130022
- Supplement
- S007
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SENZA SPINAL CORD STIMULATION (SCS) SYSTEM
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Nevro Corporation
- Date received
- 2016-04-11
- Decision date
- 2016-11-18
- Days to decision
- 221 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Redwood City, CA
- Statement
- Approval to use a larger volume of sterilization load (from 4 pallets to 10 pallets) for the ethylene oxide (EO) sterilization of Senza SCS System products.
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