FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation
PMA: P100046
·
Supplement: S018
·
Decision Mar 15, 2024
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
- S018
- 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
- March 15, 2024
- Date Received
- February 16, 2024
- Supplement Type
- Special (Immediate Track)
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of your premarket approval application (PMA) supplement, which requested approval for labeling changes.
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 |