PMA P130028S006
- Device
- ALGOVITA SPINAL CORD STIMULATION SYSTEM
- Applicant
- Nuvectra Corporation
- PMA number
- P130028
- Supplement
- S006
- Product code
- LGW
- Decision date
- 2016-05-13
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order 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.
Current openFDA PMA Record#
- Device
- ALGOVITA SPINAL CORD STIMULATION SYSTEM
- Applicant
- Nuvectra Corporation
- PMA number
- P130028
- Supplement
- S006
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2016-05-13
- Decision code
- OK30
- Date received
- 2016-04-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order 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.