PMA supplement
P960004 S114: Straight Lead Stylets Limber Models 6033, 6034; Straight Lead Stylets Firm Models 6036, 6037; J Shaped Lead Stylets Limb
FDA PMA supplement · Real-Time Process · Boston Scientific
Key facts
| Original PMA | P960004 |
|---|---|
| Supplement number | S114 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | Straight Lead Stylets Limber Models 6033, 6034; Straight Lead Stylets Firm Models 6036, 6037; J Shaped Lead Stylets Limb |
| Generic name | Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes |
| Applicant | Boston Scientific |
| Product code | NVN |
| Received date | Feb 4, 2026 |
| Decision date | Apr 10, 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: