PMA P130028S008
- Device
- ALGOVITA SPINAL CORD STIMULATION SYSTEM
- Applicant
- Nuvectra Corporation
- PMA number
- P130028
- Supplement
- S008
- Product code
- LGW
- Decision date
- 2016-06-22
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- Use of an alternate polycarbonate/acrylonitrile butadiene styrene (PC/ABS) resin material to manufacture the lower housing of the Trial Cable Interface assembly.
Current openFDA PMA Record#
- Device
- ALGOVITA SPINAL CORD STIMULATION SYSTEM
- Applicant
- Nuvectra Corporation
- PMA number
- P130028
- Supplement
- S008
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2016-06-22
- Decision code
- OK30
- Date received
- 2016-05-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Use of an alternate polycarbonate/acrylonitrile butadiene styrene (PC/ABS) resin material to manufacture the lower housing of the Trial Cable Interface assembly.