PMA
P050034: IMPLANTABLE MINIATURE TELESCOPE (IMT)
FDA PMA · Telescope, implantable, miniature · Samsara Vision, Inc.
Key facts
| PMA number | P050034 |
|---|---|
| Trade name | IMPLANTABLE MINIATURE TELESCOPE (IMT) |
| Generic name | Telescope, implantable, miniature |
| Applicant | Samsara Vision, Inc. |
| Owner/operator | Samsara Vision Inc. |
| Product code | NCJ |
| Approval date | Jul 1, 2010 |
| Docket number | 10M-0361 |
| Notice date | Jul 7, 2010 |
| Establishment registration | 3005347768 |
| FEI number | 3005347768 |
At a glance
- 10–99 Supplements
- Dec 17, 2024 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- No Withdrawn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: