PMA supplement
P030023 S001: OPHTEC CAPSULAR TENSION RING MODELS 276 AND 275 AND STABILEYES MODELS STBL2US AND STBL13US
FDA PMA supplement · Normal 180 Day Track No User Fee · Ophtec BV
Key facts
| Original PMA | P030023 |
|---|---|
| Supplement number | S001 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | OPHTEC CAPSULAR TENSION RING MODELS 276 AND 275 AND STABILEYES MODELS STBL2US AND STBL13US |
| Generic name | Ring, endocapsular |
| Applicant | Ophtec BV |
| Product code | MRJ |
| Received date | Oct 19, 2011 |
| Decision date | Dec 14, 2011 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: