PMA supplement
P960016 S085: Livewire TC Ablation Catheter, Livewire TC Cables, Safire Ablation Catheter, Safire Cables
FDA PMA supplement · 30-Day Notice · St Jude Medical
Key facts
| Original PMA | P960016 |
|---|---|
| Supplement number | S085 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | Livewire TC Ablation Catheter, Livewire TC Cables, Safire Ablation Catheter, Safire Cables |
| Generic name | Cardiac ablation percutaneous catheter |
| Applicant | St Jude Medical |
| Product code | LPB |
| Received date | Sep 18, 2020 |
| Decision date | Oct 16, 2020 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: