Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation
The Surgical Cardiac Ablation Device for Atrial Fibrillation (product code OCM) is a cardiovascular surgical device used to perform cardiac ablation for the treatment of atrial fibrillation, typically as part of open-heart or minimally invasive cardiac surgery. Ablation creates lesions in cardiac tissue to interrupt abnormal electrical pathways responsible for atrial fibrillation. This device is FDA Class 3, the highest risk category, requiring Premarket Approval (PMA) given the critical nature of the cardiac application; it has no assigned regulation number or medical specialty code. It carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- OCM
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- CV
- Submission Type
- 2
Device Characteristics
Definition
Surgical cardiac ablation for the treatment of atrial fibrillation.
FEI Numbers
This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.