NEVRO SENZA SPINAL CORD STIMULATION (SCS) SYSTEM
FDA premarket approval P130022/S006 · decided 2016-04-15
Approval details
- PMA number
- P130022
- Supplement
- S006
- 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
- 2016-03-16
- Decision date
- 2016-04-15
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Redwood City, CA
- Statement
- Process changes to the manufacture of the spinal cord stimulator system battery charger, including the addition of an adhesive to a component on the printed circuit board (PCB), minor alterations to the PCB layout to improve manufacturability, and the addition of torque wrenches to its manufacturing process.
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