PMA supplement
P910001 S116: ELCA Coronoary Laser Atherectomy Catheter
FDA PMA supplement · Real-Time Process · Spectranetics Corp.
Key facts
| Original PMA | P910001 |
|---|---|
| Supplement number | S116 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | ELCA Coronoary Laser Atherectomy Catheter |
| Generic name | DEVICE, ANGIOPLASTY, LASER, CORONARY |
| Applicant | Spectranetics Corp. |
| Product code | LPC |
| Received date | Jun 17, 2022 |
| Decision date | Aug 19, 2022 |
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: