PMA supplement
P020025 S117: Blazere II Ablation Catheters, Blazer II XP Ablation Catheters, Blazer Prime Ablation Catheters
FDA PMA supplement · 30-Day Notice · Boston Scientific
Key facts
| Original PMA | P020025 |
|---|---|
| Supplement number | S117 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | Blazere II Ablation Catheters, Blazer II XP Ablation Catheters, Blazer Prime Ablation Catheters |
| Generic name | Catheter, percutaneous, cardiac ablation, for treatment of atrial flutter |
| Applicant | Boston Scientific |
| Product code | OAD |
| Received date | Mar 21, 2019 |
| Decision date | Apr 16, 2019 |
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: