PMA supplement
P960004 S115: Stylet (Models 6033, 6034, 6036, 6037, 6039, 6040, 6042, 6043, 6053, 6054, 6055, 6058, 6059, 6062, 6063, 6064, 6065, 606
FDA PMA supplement · 30-Day Notice · Boston Scientific
Key facts
| Original PMA | P960004 |
|---|---|
| Supplement number | S115 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | Stylet (Models 6033, 6034, 6036, 6037, 6039, 6040, 6042, 6043, 6053, 6054, 6055, 6058, 6059, 6062, 6063, 6064, 6065, 606 |
| Generic name | Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes |
| Applicant | Boston Scientific |
| Product code | NVN |
| Received date | Apr 17, 2026 |
| Decision date | May 15, 2026 |
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: