Stimulator, Spinal-Cord, Implanted For Peripheral Vascular Disease
Stimulator, Spinal-Cord, Implanted for Peripheral Vascular Disease is a surgically implanted spinal cord stimulation device that delivers electrical impulses to the spinal cord to reduce pain and improve blood flow in patients with peripheral vascular disease who have not responded to conventional treatments. This is an FDA Class 3 device, the highest risk category, requiring Premarket Approval (PMA). The product code is LLE; no regulation number has been assigned, and the review panel is Neurology. This device is an implant.
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Basic Information
- Product Code
- LLE
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- NE
- Submission Type
- 3
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.