FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation
PMA: P100046
·
Supplement: S001
·
Decision Aug 15, 2012
Classifications
1
FEI Numbers
9
Registration Numbers
9
Basic Information
- Device Name
- Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation
- Trade Name
- ATRICURE SYNERGY ABLATION SYSTEM
- PMA Number
- P100046
- Supplement Number
- S001
- 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
- August 15, 2012
- Date Received
- February 14, 2012
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Postapproval Study Protocol - OSB
- Expedited Review
- N
Advisory Committee Statement
APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
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 |