PMA supplement
P910001 S023: CVX-300 EXCIMER LASER CORONARY ANGIOPLASTY (ELCA) SYSTEM
FDA PMA supplement · Normal 180 Day Track No User Fee · Spectranetics Corp.
Key facts
| Original PMA | P910001 |
|---|---|
| Supplement number | S023 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | CVX-300 EXCIMER LASER CORONARY ANGIOPLASTY (ELCA) SYSTEM |
| Generic name | DEVICE, ANGIOPLASTY, LASER, CORONARY |
| Applicant | Spectranetics Corp. |
| Product code | LPC |
| Received date | Jan 31, 2003 |
| Decision date | May 2, 2003 |
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: