PMA
P910073: ENDOTAK LEAD SYSTEM
FDA PMA · Implantable cardioverter defibrillator (non-CRT) · Boston Scientific
Key facts
| PMA number | P910073 |
|---|---|
| Trade name | ENDOTAK LEAD SYSTEM |
| Generic name | Implantable cardioverter defibrillator (non-CRT) |
| Applicant | Boston Scientific |
| Owner/operator | Boston Scientific Corporation |
| Product code | LWS |
| Approval date | Aug 26, 1993 |
| Docket number | 94M-0064 |
| Notice date | Apr 19, 1994 |
| Establishment registration | 2124215 |
| FEI number | 2124215 |
At a glance
- 100–999 Supplements
- Sep 17, 2026 Latest supplement decision
- No Withdrawn
- No 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: