PMA
P850027: TELECTRONICS PASAR MODEL 4171 PG
FDA PMA · PULSE-GENERATOR, SINGLE CHAMBER, SINGLE · Telectronics, Inc.
Key facts
| PMA number | P850027 |
|---|---|
| Trade name | TELECTRONICS PASAR MODEL 4171 PG |
| Generic name | PULSE-GENERATOR, SINGLE CHAMBER, SINGLE |
| Applicant | Telectronics, Inc. |
| Product code | LWW |
| Approval date | Sep 30, 1986 |
| Docket number | 86M-0402 |
| Notice date | Nov 10, 1986 |
At a glance
- 1–9 Supplements
- May 9, 1990 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- None 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: