PMA P130028S012
- Device
- ALGOVITA SPINAL CORD STIMULATION SYSTEM
- Applicant
- Nuvectra Corporation
- PMA number
- P130028
- Supplement
- S012
- Product code
- LGW
- Decision date
- 2016-08-19
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- Changes to update the battery manufacturing equipment and addition of an alternate supplier for a wire battery component.
Current openFDA PMA Record#
- Device
- ALGOVITA SPINAL CORD STIMULATION SYSTEM
- Applicant
- Nuvectra Corporation
- PMA number
- P130028
- Supplement
- S012
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2016-08-19
- Decision code
- OK30
- Date received
- 2016-07-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to update the battery manufacturing equipment and addition of an alternate supplier for a wire battery component.