PMA
P830060: VENTAK AND AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEMS
FDA PMA · Implantable cardioverter defibrillator (non-CRT) · Boston Scientific
Key facts
| PMA number | P830060 |
|---|---|
| Trade name | VENTAK AND AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEMS |
| Generic name | Implantable cardioverter defibrillator (non-CRT) |
| Applicant | Boston Scientific |
| Owner/operator | Boston Scientific Corporation |
| Product code | LWS |
| Approval date | Oct 4, 1985 |
| Docket number | 85M-0504 |
| Notice date | Nov 15, 1985 |
| Establishment registration | 2124215 |
| FEI number | 2124215 |
At a glance
- 10–99 Supplements
- May 15, 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- No Withdrawn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: