PMA supplement
P940010 S012: OPTIGUIDE Fiber Optic Diffuser (DCYL Cylindrical Diffuser Series)
FDA PMA supplement · Real-Time Process · Pinnacle Biologics, Inc.
Key facts
| Original PMA | P940010 |
|---|---|
| Supplement number | S012 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | OPTIGUIDE Fiber Optic Diffuser (DCYL Cylindrical Diffuser Series) |
| Generic name | System, laser, fiber optic, photodynamic therapy |
| Applicant | Pinnacle Biologics, Inc. |
| Product code | MVG |
| Received date | Oct 24, 2017 |
| Decision date | Jan 17, 2018 |
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: