PMA
P960042: SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM & LASER SHEATH
FDA PMA · DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS · Spectranetics (Philips)
Key facts
| PMA number | P960042 |
|---|---|
| Trade name | SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM & LASER SHEATH |
| Generic name | DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS |
| Applicant | Spectranetics (Philips) |
| Owner/operator | Philips Medical Systems International BV |
| Product code | MFA |
| Approval date | Dec 9, 1997 |
| Docket number | 98M-0451 |
| Notice date | Jul 14, 1998 |
| Establishment registration | 3007284006 |
| FEI number | 3007284006 |
At a glance
- 10–99 Supplements
- Dec 18, 2025 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- None 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: