NEVRO SENZA SPINAL CORD STIMULATION (SCS) SYSTEM
FDA premarket approval P130022/S012 · decided 2017-03-01
Approval details
- PMA number
- P130022
- Supplement
- S012
- 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
- 2017-02-01
- Decision date
- 2017-03-01
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Redwood City, CA
- Statement
- Implement manufacturing process changes to allow for the use of virtual machine software (VMware) to provide an isolated and safe environment fromwhich to run the FDA approved PG2000 Clinician Programmer software v1.7.
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