PMA
P940010: OPTIGUIDE(TM) FIBER OPTIC DIFFUSER
FDA PMA · System, laser, fiber optic, photodynamic therapy · Pinnacle Biologics, Inc.
Key facts
| PMA number | P940010 |
|---|---|
| Trade name | OPTIGUIDE(TM) FIBER OPTIC DIFFUSER |
| Generic name | System, laser, fiber optic, photodynamic therapy |
| Applicant | Pinnacle Biologics, Inc. |
| Owner/operator | Advanz Pharma (US) Corp. |
| Product code | MVG |
| Approval date | Dec 27, 1995 |
| Docket number | 97M-0204 |
| Establishment registration | 3010119152 |
| FEI number | 3010119152 |
At a glance
- 10–99 Supplements
- Feb 24, 2021 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 10–99 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: