FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation
PMA: P100046
·
Supplement: S008
·
Decision Oct 5, 2016
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
- S008
- 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
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- October 5, 2016
- Date Received
- September 1, 2016
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Add an additional site for citric passivating the proximal jaws of the end effector on the OLL2 and OSL2 Synergy Ablation Clamps.
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 |