FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
PMA: P060019
·
Supplement: S058
·
Decision Dec 19, 2025
Classifications
1
FEI Numbers
0
Registration Numbers
0
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Basic Information
- Device Name
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
- Trade Name
- Cool Point Tubing Set
- PMA Number
- P060019
- Supplement Number
- S058
- Device Class
- FDA Class 3
- Product Code
- OAD
- Generic Name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- December 19, 2025
- Date Received
- December 2, 2025
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
changes in polycarbonate resins, adhesives, and luers with minor dimensional 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 |
|---|---|---|---|
| OAD | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter | FDA class 3 | Unknown |