PMA
P110042: SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM
FDA PMA · Implantable cardioverter defibrillator (non-CRT) · Boston Scientific Corporation
Key facts
| PMA number | P110042 |
|---|---|
| Trade name | SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM |
| Generic name | Implantable cardioverter defibrillator (non-CRT) |
| Applicant | Boston Scientific Corporation |
| Owner/operator | Boston Scientific Corporation |
| Product code | LWS |
| Approval date | Sep 28, 2012 |
| Docket number | 12M-1048 |
| Notice date | Nov 1, 2012 |
| Establishment registration | 2124215 |
| FEI number | 2124215 |
At a glance
- 100–999 Supplements
- Oct 2, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: