PMA
P970029: TMR HOLMIUM LASER SYSTEM
FDA PMA · SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION · Cryolife, Inc.
Key facts
| PMA number | P970029 |
|---|---|
| Trade name | TMR HOLMIUM LASER SYSTEM |
| Generic name | SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION |
| Applicant | Cryolife, Inc. |
| Owner/operator | Artivion, Inc. |
| Product code | MNO |
| Approval date | Feb 11, 1999 |
| Docket number | 99M-2238 |
| Notice date | Jul 19, 1999 |
| Establishment registration | 1063481 |
| FEI number | 3001451326 |
At a glance
- 10–99 Supplements
- Sep 1, 2022 Latest supplement decision
- No Withdrawn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: