PMA supplement
P870043 S007: 8 ECTRAPROBE-PLR MODEL 900 OPTILASE CONTACT LASER
FDA PMA supplement · Normal 180 Day Track · Trimedyne, Inc.
Key facts
| Original PMA | P870043 |
|---|---|
| Supplement number | S007 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | 8 ECTRAPROBE-PLR MODEL 900 OPTILASE CONTACT LASER |
| Generic name | DEVICE, ANGIOPLASTY, LASER, CORONARY |
| Applicant | Trimedyne, Inc. |
| Product code | LPC |
| Received date | Feb 3, 1989 |
| Decision date | Sep 12, 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: