Senza Spinal Cord Stimulation (SCS) System
FDA premarket approval P130022/S034 · decided 2021-05-21
Approval details
- PMA number
- P130022
- Supplement
- S034
- 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
- 2020-05-18
- Decision date
- 2021-05-21
- Days to decision
- 368 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Redwood City, CA
- Statement
- Approval for the addition of an alternative site, Cirtec Medical Corporation Free Zone Coyol, Building 11 Costa Rica CR 20101, as a back up to the primary site Cirtec Medical, formerly known as Stellar, Brooklyn Park, MN for the manufacturing of the percutaneous lead components to accommodate higher volume manufacturing.
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