SENZA SPINAL CORD STIMULATION (SCS) SYSTEM
FDA premarket approval P130022/S010 · decided 2016-12-28
Approval details
- PMA number
- P130022
- Supplement
- S010
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location 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
- 2016-10-20
- Decision date
- 2016-12-28
- Days to decision
- 69 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Redwood City, CA
- Statement
- Approval for a manufacturing site located at Pro-Tech, 4041 Express Street, Arlington, Texas for kitting of components in cleanrooms, final packaging including labeling and visual inspection of the final product prior to shipment for sterilization.
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