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

Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

Unknown
FDA source (opens on fda.gov)

OCM is the FDA product code for Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation, a class III device type. FDA's definition for this code reads: "Surgical cardiac ablation for the treatment of atrial fibrillation". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
OCM
Device name
Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation
FDA definition
Surgical cardiac ablation for the treatment of atrial fibrillation.
Device class
Class III
Review panel
Unknown
Submission type
PMA
Implant
No
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