PMA supplement
P850027 S005: TELECTRONICS PASAR MODEL 4171 PG
FDA PMA supplement · Normal 180 Day Track · Telectronics, Inc.
Key facts
| Original PMA | P850027 |
|---|---|
| Supplement number | S005 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Other |
| Trade name | TELECTRONICS PASAR MODEL 4171 PG |
| Generic name | PULSE-GENERATOR, SINGLE CHAMBER, SINGLE |
| Applicant | Telectronics, Inc. |
| Product code | LWW |
| Received date | Jan 16, 1990 |
| Decision date | Feb 2, 1990 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: