PMA P130028S030
- Device
- Algovita Spinal Cord Stimulation System
- Applicant
- Nuvectra Corporation
- PMA number
- P130028
- Supplement
- S030
- Product code
- LGW
- Decision date
- 2019-10-25
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- Addition of an alternate supplier of the silicone seals used to manufacture the header assembly of the Algovita Implantable Pulse Generators (IPGs).
Current openFDA PMA Record#
- Device
- Algovita Spinal Cord Stimulation System
- Applicant
- Nuvectra Corporation
- PMA number
- P130028
- Supplement
- S030
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2019-10-25
- Decision code
- OK30
- Date received
- 2019-09-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of an alternate supplier of the silicone seals used to manufacture the header assembly of the Algovita Implantable Pulse Generators (IPGs).