PMA
P950015: THE HEART LASER TM CO2 LASER SYSTEM FOR TRANSMYOCARDIAL REVASCULARIZATION
FDA PMA · SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION · Laser Engineering Heart, Inc.
Key facts
| PMA number | P950015 |
|---|---|
| Trade name | THE HEART LASER TM CO2 LASER SYSTEM FOR TRANSMYOCARDIAL REVASCULARIZATION |
| Generic name | SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION |
| Applicant | Laser Engineering Heart, Inc. |
| Owner/operator | Laser Engineering Inc |
| Product code | MNO |
| Approval date | Aug 20, 1998 |
| Docket number | 99M-2672 |
| Notice date | Aug 17, 1999 |
| Establishment registration | 1060848 |
| FEI number | 3000204219 |
At a glance
- 10–99 Supplements
- Jul 23, 2014 Latest supplement decision
- Yes Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 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: