ALGOVITA SPINAL CORD STIMULATION SYSTEM
FDA premarket approval P130028/S006 · decided 2016-05-13
Approval details
- PMA number
- P130028
- Supplement
- S006
- Supplement type
- 30-Day Notice
- 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
- 2016-04-13
- Decision date
- 2016-05-13
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Blaine, MN
- Statement
- Optional replacement of a diode hand-soldering process with an automated surface mount technology process and optional replacement of an uncoated wire with a zero Ohm resistor on the printed circuit boards for the Model 4200 patient programmer charger of your Algovita Spinal Cord Stimulation system.
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