PMA
P030023: OPHTEC CAPSULAR TENSION RING MODELS 276 AND 275 AND STABILEYES MODELS STBL2US AND STBL13US
FDA PMA · Ring, endocapsular · Ophtec BV
Key facts
| PMA number | P030023 |
|---|---|
| Trade name | OPHTEC CAPSULAR TENSION RING MODELS 276 AND 275 AND STABILEYES MODELS STBL2US AND STBL13US |
| Generic name | Ring, endocapsular |
| Applicant | Ophtec BV |
| Owner/operator | OPHTEC USA |
| Product code | MRJ |
| Approval date | Apr 27, 2004 |
| Docket number | 04M-0248 |
| Notice date | May 26, 2004 |
| Establishment registration | 8040449 |
| FEI number | 3002501070 |
At a glance
- 10–99 Supplements
- Oct 6, 2025 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- No Withdrawn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: