ALGOVITA SPINAL CORD STIMULATION SYSTEM
FDA premarket approval P130028/S013 · decided 2017-02-07
Approval details
- PMA number
- P130028
- Supplement
- S013
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ALGOVITA SPINAL CORD STIMULATION SYSTEM
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Nuvectra Corporation
- Date received
- 2017-01-13
- Decision date
- 2017-02-07
- Days to decision
- 25 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Blaine, MN
- Statement
- Approval for quality control changes that impact the manufacturing process for Algovita Percutaneous Leads and Trial Leads
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