PMA supplement
P150005 S014: Blazer Open-Irrigated Ablation Catheter and IntellaNav Open-Irrigated Ablation Catheter
FDA PMA supplement · Panel Track · Boston Scientific Corp
Key facts
| Original PMA | P150005 |
|---|---|
| Supplement number | S014 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | Blazer Open-Irrigated Ablation Catheter and IntellaNav Open-Irrigated Ablation Catheter |
| Generic name | Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation |
| Applicant | Boston Scientific Corp |
| Product code | OAE |
| Received date | Feb 22, 2017 |
| Decision date | Dec 21, 2017 |
| Docket number | 17M-6970 |
| Notice date | Jan 23, 2018 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes 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: