PMA supplement
P110042 S204: Subcutaneous Implantable Cardioverter Defibrillator (S-ICD): EMBLEM S-ICD Model A209 and EMBLEM MRI S-ICD Model A219
FDA PMA supplement · 135 Review Track For 30-Day Notice · Boston Scientific Corporation
Key facts
| Original PMA | P110042 |
|---|---|
| Supplement number | S204 |
| Supplement type | 135 Review Track For 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | Subcutaneous Implantable Cardioverter Defibrillator (S-ICD): EMBLEM S-ICD Model A209 and EMBLEM MRI S-ICD Model A219 |
| Generic name | Implantable cardioverter defibrillator (non-CRT) |
| Applicant | Boston Scientific Corporation |
| Product code | LWS |
| Received date | Jul 15, 2025 |
| Decision date | Jan 8, 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: