PMA
P900032: AIS EXIMER LASER ANGIOPLASTY
FDA PMA · DEVICE, ANGIOPLASTY, LASER, CORONARY · Spectranetics Corp.
Key facts
| PMA number | P900032 |
|---|---|
| Trade name | AIS EXIMER LASER ANGIOPLASTY |
| Generic name | DEVICE, ANGIOPLASTY, LASER, CORONARY |
| Applicant | Spectranetics Corp. |
| Owner/operator | Philips Medical Systems International BV |
| Product code | LPC |
| Approval date | Jan 31, 1992 |
| Docket number | 92M-0078 |
| Notice date | Mar 16, 1992 |
| Establishment registration | 3007284006 |
| FEI number | 3007284006 |
At a glance
- 10–99 Supplements
- Jun 14, 1994 Latest supplement decision
- Yes Withdrawn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: