ALGOVITA SPINAL CORD STIMULATION SYSTEM
FDA premarket approval P130028/S004 · decided 2016-06-10
Approval details
- PMA number
- P130028
- Supplement
- S004
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ALGOVITA SPINAL CORD STIMULATION SYSTEM
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Nuvectra Corporation
- Date received
- 2016-03-14
- Decision date
- 2016-06-10
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Blaine, MN
- Statement
- Approval for the following changes to the 8- and 12-electrode lead extensions for your Algovita Spinal Cord Stimulation System:1) Decreasing your design specifications for the maximum insertion/withdrawal force from 2.0 lbf to 1.5 lbf;2) Revising your supplier shipping requirements for the spring system connector subassembly to have the subassembly shipped while threaded on a core pin; and 3) Elimination of the distal end strain relief.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.