PMA P130028S029
- Device
- Algovita Spinal Cord Stimulation System
- Applicant
- Nuvectra Corporation
- PMA number
- P130028
- Supplement
- S029
- Product code
- LGW
- Decision date
- 2019-09-19
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- Implementation of an additional bonding step to the manufacturing process of the printed circuit board assembly to provide reinforcement to the interface between the micro USB connector and the circuit board.
Current openFDA PMA Record#
- Device
- Algovita Spinal Cord Stimulation System
- Applicant
- Nuvectra Corporation
- PMA number
- P130028
- Supplement
- S029
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2019-09-19
- Decision code
- OK30
- Date received
- 2019-08-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of an additional bonding step to the manufacturing process of the printed circuit board assembly to provide reinforcement to the interface between the micro USB connector and the circuit board.