510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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LLEClass III

Stimulator, Spinal-Cord, Implanted For Peripheral Vascular Disease

Unknown
FDA source (opens on fda.gov)

LLE is the FDA product code for Stimulator, Spinal-Cord, Implanted For Peripheral Vascular Disease, a class III device type. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LLE
Device name
Stimulator, Spinal-Cord, Implanted For Peripheral Vascular Disease
Device class
Class III
Review panel
Unknown
Submission type
Contact ODE
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code LLE

By decision year
2 clearances under product code LLE with a decision year between 1983 and 1984, 1983 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code LLE by decision year
YearClearances
19831
19841

Applicants with the most clearances

Product code LLE
Applicants holding the most 510(k) clearances under product code LLE
ApplicantClearances
Critikon Company, LLC1
Medical Intelcom, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code LLE.