PMA supplement
P010059 S006: FortiEYE CAPSULAR TENSION RINGS, TYPES 14, 14A AND 14C
FDA PMA supplement · Normal 180 Day Track No User Fee · Morcher GmbH
Key facts
| Original PMA | P010059 |
|---|---|
| Supplement number | S006 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | FortiEYE CAPSULAR TENSION RINGS, TYPES 14, 14A AND 14C |
| Generic name | Ring, endocapsular |
| Applicant | Morcher GmbH |
| Product code | MRJ |
| Received date | Aug 2, 2016 |
| Decision date | Jan 26, 2017 |
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: