Algovita Spinal Cord Stimulation System
FDA premarket approval P130028/S024 · decided 2019-07-03
Approval details
- PMA number
- P130028
- Supplement
- S024
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Algovita Spinal Cord Stimulation System
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Nuvectra Corporation
- Date received
- 2019-06-05
- Decision date
- 2019-07-03
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Blaine, MN
- Statement
- Incorporate a process improvement to the injection molding process for the distal subassembly of the 12 Electrode Percutaneous Leads and Trial Leads with compact spacing.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.