PMA P130028S027
- Device
- Algovita Spinal Cord Stimulation System
- Applicant
- Nuvectra Corporation
- PMA number
- P130028
- Supplement
- S027
- Product code
- LGW
- Decision date
- 2019-08-28
- 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 update to the injection molding process for the distal subassembly of the Algovita® 12-Electrode Percutaneous Leads, Trial Leads, and LeadExtensions.
Current openFDA PMA Record#
- Device
- Algovita Spinal Cord Stimulation System
- Applicant
- Nuvectra Corporation
- PMA number
- P130028
- Supplement
- S027
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2019-08-28
- Decision code
- OK30
- Date received
- 2019-07-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of an update to the injection molding process for the distal subassembly of the Algovita® 12-Electrode Percutaneous Leads, Trial Leads, and LeadExtensions.