PMA
P930035: VENTAK(R) P2 SYSTEM
FDA PMA · Implantable cardioverter defibrillator (non-CRT) · Boston Scientific
Key facts
| PMA number | P930035 |
|---|---|
| Trade name | VENTAK(R) P2 SYSTEM |
| Generic name | Implantable cardioverter defibrillator (non-CRT) |
| Applicant | Boston Scientific |
| Owner/operator | Boston Scientific Corporation |
| Product code | LWS |
| Approval date | Mar 10, 1995 |
| Docket number | 95M-0072 |
| Notice date | Apr 21, 1995 |
| 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- No Withdrawn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
- 1–9 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: