PMA supplement
P050034 S009: IMPLANTABLE MINIATURE TELESCOPE (IMT) MODELS WIDE ANGLE 2.2X AND WIDE ANGLE 2.7X
FDA PMA supplement · Normal 180 Day Track No User Fee · Samsara Vision, Inc.
Key facts
| Original PMA | P050034 |
|---|---|
| Supplement number | S009 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Labeling Change - PAS |
| Trade name | IMPLANTABLE MINIATURE TELESCOPE (IMT) MODELS WIDE ANGLE 2.2X AND WIDE ANGLE 2.7X |
| Generic name | Telescope, implantable, miniature |
| Applicant | Samsara Vision, Inc. |
| Product code | NCJ |
| Received date | May 15, 2013 |
| Decision date | Nov 5, 2013 |
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: