FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Cardiac Ablation Percutaneous Catheter
PMA: P960016
·
Supplement: S093
·
Decision Jan 15, 2026
Classifications
1
FEI Numbers
0
Registration Numbers
0
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Basic Information
- Device Name
- Cardiac Ablation Percutaneous Catheter
- Trade Name
- Livewire TC XLS
- PMA Number
- P960016
- Supplement Number
- S093
- Device Class
- FDA Class 3
- Product Code
- LPB
- Generic Name
- Cardiac ablation percutaneous catheter
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- January 15, 2026
- Date Received
- December 17, 2025
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
an alternate vapor degreaser which is used as a processing aid to remove metalworking cutting fluid on patient-contacting tip electrodes and electrode rings during manufacturing
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 |
|---|---|---|---|
| LPB | Cardiac Ablation Percutaneous Catheter | FDA class 3 | Unknown |