PMA supplement
P860042 S012: TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE
FDA PMA supplement · Normal 180 Day Track · Trimedyne, Inc.
Key facts
| Original PMA | P860042 |
|---|---|
| Supplement number | S012 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE |
| Generic name | Device. Laser peripheral angioplasty |
| Applicant | Trimedyne, Inc. |
| Product code | LWX |
| Received date | Dec 27, 1988 |
| Decision date | Jun 6, 1989 |
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: