PMA supplement
P910001 S109: CVX-300 Excimer Laser System and ELCA Coronary Atherectomy Catheters
FDA PMA supplement · 135 Review Track For 30-Day Notice · Spectranetics Corp.
Key facts
| Original PMA | P910001 |
|---|---|
| Supplement number | S109 |
| Supplement type | 135 Review Track For 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | CVX-300 Excimer Laser System and ELCA Coronary Atherectomy Catheters |
| Generic name | DEVICE, ANGIOPLASTY, LASER, CORONARY |
| Applicant | Spectranetics Corp. |
| Product code | LPC |
| Received date | Dec 26, 2018 |
| Decision date | Mar 20, 2019 |
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: