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

Permanent Defibrillator Electrodes

Unknown
FDA source (opens on fda.gov)

NVY is the FDA product code for Permanent Defibrillator Electrodes, a class III device type. FDA's definition for this code reads: "Permanent defibrillator electrodes are used with compatible implantable cardioverter defibrillators (ICD) and cardiac rhythm therapy-defibrillators (CRT-D) to sense the cardiac rhythm and to deliver high energy therapy to the heart when tachycardia is detected. Some transvenous models can also be used for pacing the...". As of , FDA records hold no 510(k) clearances under this code and 5 recalls.

Classification record

Product code
NVY
Device name
Permanent Defibrillator Electrodes
FDA definition
Permanent defibrillator electrodes are used with compatible implantable cardioverter defibrillators (ICD) and cardiac rhythm therapy-defibrillators (CRT-D) to sense the cardiac rhythm and to deliver high energy therapy to the heart when tachycardia is detected. Some transvenous models can also be used for pacing the right ventricle.
Device class
Class III
Review panel
Unknown
Submission type
PMA
Implant
Yes
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
5

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 27 companies shown, in name order