PMA
P910001: SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM
FDA PMA · DEVICE, ANGIOPLASTY, LASER, CORONARY · Spectranetics Corp.
Key facts
| PMA number | P910001 |
|---|---|
| Trade name | SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM |
| Generic name | DEVICE, ANGIOPLASTY, LASER, CORONARY |
| Applicant | Spectranetics Corp. |
| Owner/operator | Philips Medical Systems International BV |
| Product code | LPC |
| Approval date | Feb 19, 1993 |
| Docket number | 93M-0086 |
| Notice date | Mar 24, 1993 |
| Establishment registration | 3007284006 |
| FEI number | 3007284006 |
At a glance
- 100–999 Supplements
- Aug 21, 2026 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 10–99 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: