PMA
P970002: MONOSTRUT CARDIAC VALVE PROSTHESIS
FDA PMA · HEART-VALVE, MECHANICAL · Alliance Medical Technologies, Inc.
Key facts
| PMA number | P970002 |
|---|---|
| Trade name | MONOSTRUT CARDIAC VALVE PROSTHESIS |
| Generic name | HEART-VALVE, MECHANICAL |
| Applicant | Alliance Medical Technologies, Inc. |
| Owner/operator | AB Medical Technologies, Inc. |
| Product code | LWQ |
| Approval date | Sep 30, 1997 |
| Docket number | 98M-0200 |
| Notice date | Apr 7, 1998 |
| Establishment registration | 3010356635 |
| FEI number | 1000123848 |
At a glance
- 1–9 Supplements
- Mar 23, 1998 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- No Withdrawn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: