PMA supplement
P910001 S082: ELCA CORONARY LASER ATHERCOTOMY CATHETER (ELCA 2.0 VITESSE ELL)
FDA PMA supplement · 30-Day Notice · Spectranetics Corp.
Key facts
| Original PMA | P910001 |
|---|---|
| Supplement number | S082 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | ELCA CORONARY LASER ATHERCOTOMY CATHETER (ELCA 2.0 VITESSE ELL) |
| Generic name | DEVICE, ANGIOPLASTY, LASER, CORONARY |
| Applicant | Spectranetics Corp. |
| Product code | LPC |
| Received date | Nov 25, 2015 |
| Decision date | Dec 18, 2015 |
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: