Product Code: LLE FDA class 3

Stimulator, Spinal-Cord, Implanted For Peripheral Vascular Disease

Unknown

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.

510(k)s
2
FEI Numbers
0
Registration Numbers
0
Unique Applicants
2
Years Active
0

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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

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 2 510(k) clearances via K numbers.

K Number Device Name
K833430 BLOOD GAS EXPERSYSTEM 8700
K832916 INIVOX ELECTRODE/CATHETER SYS