PMA
P150039: TRYTON SIDE BRANCH STENT
FDA PMA · STENT, CORONARY · Poseidon Medical, Inc.
Key facts
| PMA number | P150039 |
|---|---|
| Trade name | TRYTON SIDE BRANCH STENT |
| Generic name | STENT, CORONARY |
| Applicant | Poseidon Medical, Inc. |
| Owner/operator | Poseidon Medical Inc. |
| Product code | MAF |
| Approval date | Feb 21, 2017 |
| Docket number | 17M-1121 |
| Notice date | Feb 27, 2017 |
| Establishment registration | 3016248656 |
| FEI number | 3016248656 |
At a glance
- 1–9 Supplements
- Oct 4, 2020 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- No Withdrawn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: