FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
PMA: P240013
·
Supplement: S022
·
Decision May 28, 2026
Classifications
1
FEI Numbers
0
Registration Numbers
0
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Basic Information
- Device Name
- Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
- Trade Name
- Affera Ablation System
- PMA Number
- P240013
- Supplement Number
- S022
- Device Class
- FDA Class 3
- Product Code
- QZI
- Generic Name
- Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- May 28, 2026
- Date Received
- February 27, 2026
- Supplement Type
- Real-Time Process
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
approval for minor labeling updates to the Affera Ablation System User Manual to reflect expanded connectivity options on the modified Affera System Cart
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 |
|---|---|---|---|
| QZI | Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation | FDA class 3 | Unknown |