FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation
PMA: P100046
·
Supplement: S017
·
Decision Nov 22, 2023
Classifications
1
FEI Numbers
9
Registration Numbers
9
Basic Information
- Device Name
- Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation
- Trade Name
- Synergy Ablation System
- PMA Number
- P100046
- Supplement Number
- S017
- 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
- November 22, 2023
- Date Received
- August 31, 2023
- Supplement Type
- Real-Time Process
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
Approval for minor software modifications to the Multifunctional Ablation Generator (MAG) system controller software.
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 |