PMA
P930024: GRIESHABER SCLERAL BUCKLING BALLOON CATHETER
FDA PMA · Catheter, balloon for retinal reattachment · Labtician Ophthalmics, Inc.
Key facts
| PMA number | P930024 |
|---|---|
| Trade name | GRIESHABER SCLERAL BUCKLING BALLOON CATHETER |
| Generic name | Catheter, balloon for retinal reattachment |
| Applicant | Labtician Ophthalmics, Inc. |
| Owner/operator | LABTICIAN OPHTHALMICS, INC. |
| Product code | LOG |
| Approval date | Jun 2, 1994 |
| Docket number | 94M-0229 |
| Notice date | Jul 22, 1994 |
| Establishment registration | 9612327 |
| FEI number | 3002807445 |
At a glance
- None Supplements
- Jun 2, 1994 Latest supplement decision
- Yes Withdrawn
- No Summary of safety and effectiveness on file
- None 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: