PMA
P910077: VENTAK(R) PRX (TM) MODEL 1700,1705 PULSE GENERATOR
FDA PMA · Implantable cardioverter defibrillator (non-CRT) · Boston Scientific
Key facts
| PMA number | P910077 |
|---|---|
| Trade name | VENTAK(R) PRX (TM) MODEL 1700,1705 PULSE GENERATOR |
| Generic name | Implantable cardioverter defibrillator (non-CRT) |
| Applicant | Boston Scientific |
| Owner/operator | Boston Scientific Corporation |
| Product code | LWS |
| Approval date | Jun 17, 1994 |
| Docket number | 94M-0241 |
| Notice date | Aug 15, 1994 |
| Establishment registration | 2124215 |
| FEI number | 2124215 |
At a glance
- 100–999 Supplements
- Jul 1, 2026 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 100–999 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: