FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation
PMA: P200002
·
Supplement: S011
·
Decision Jun 17, 2025
Classifications
1
FEI Numbers
9
Registration Numbers
9
Basic Information
- Device Name
- Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation
- Trade Name
- EPi-Sense Guided Coagulation System
- PMA Number
- P200002
- Supplement Number
- S011
- Device Class
- FDA Class 3
- Product Code
- OCM
- Generic Name
- Surgical cardiac ablation device, for treatment of atrial fibrillation
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- June 17, 2025
- Date Received
- March 24, 2025
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
an additional contract sterilizer and a process change to the ethylene oxide sterilization method
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OCM | Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation | FDA class 3 | Unknown |