FDA product code LLE: Stimulator, Spinal-Cord, Implanted For Peripheral Vascular Disease
LLE is the FDA product code for stimulator, spinal-cord, implanted for peripheral vascular disease. It is a Class III device, reviewed by the Neurology panel. FDA has cleared 2 510(k) submissions under LLE, from 2 different applicants. The average 510(k) review took 102 days (median 102).
Classification
| Field | Value |
|---|---|
| Device name | Stimulator, Spinal-Cord, Implanted For Peripheral Vascular Disease |
| Device class | Class III |
| Review panel | NE — Neurology |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
| Implant | Yes |
Compare with all 510(k) review times · Search every LLE clearance
Top LLE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medical Intelcom, Inc. | 1 | 1984-02-10 |
| Critikon Company, LLC | 1 | 1983-11-14 |
Most recent LLE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K833430 | Medical Intelcom, Inc. | BLOOD GAS EXPERSYSTEM 8700 | 1984-02-10 | 128 |
| K832916 | Critikon Company, LLC | INIVOX ELECTRODE/CATHETER SYS | 1983-11-14 | 77 |
Recalls for LLE devices
openFDA lists no recalls for product code LLE.
Frequently asked questions
What is FDA product code LLE?
LLE is the FDA product code for stimulator, spinal-cord, implanted for peripheral vascular disease. It is a Class III device, reviewed by the Neurology panel.
What device class is LLE?
Class III. Typical premarket route: Contact FDA.
How long does a 510(k) take for product code LLE?
Across 2 cleared submissions the average was 102 days from receipt to decision (median 102).
Which companies have the most LLE clearances?
Medical Intelcom, Inc. (1); Critikon Company, LLC (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LLE
- Run a recall and safety report across every LLE manufacturer
- Watch product code LLE for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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