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

Leadless Cardiac Resynchronization Therapy (Crt)

Unknown
FDA source (opens on fda.gov)

SEG is the FDA product code for Leadless Cardiac Resynchronization Therapy (Crt), a class III device type. FDA's definition for this code reads: "Leadless Cardiac Resynchronization Therapy (CRT) is intended to deliver CRT using a leadless left ventricular implant". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
SEG
Device name
Leadless Cardiac Resynchronization Therapy (Crt)
FDA definition
Leadless Cardiac Resynchronization Therapy (CRT) is intended to deliver CRT using a leadless left ventricular implant
Device class
Class III
Review panel
Unknown
Submission type
PMA
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code