ALGOVITA SPINAL CORD STIMULATION SYSTEM
FDA premarket approval P130028/S009 · decided 2016-07-14
Approval details
- PMA number
- P130028
- Supplement
- S009
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ALGOVITA SPINAL CORD STIMULATION SYSTEM
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Nuvectra Corporation
- Date received
- 2016-05-27
- Decision date
- 2016-07-14
- Days to decision
- 48 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Blaine, MN
- Statement
- Approval for software and instructions for use (IFU) changes to the Model 4500 Clinician Programmer.
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