PMA
P900067: SULFUR HEXAFLUORIDE
FDA PMA · Gases used within eye to place pressure on detached retina · Airgas Therapeutics, LLC
Key facts
| PMA number | P900067 |
|---|---|
| Trade name | SULFUR HEXAFLUORIDE |
| Generic name | Gases used within eye to place pressure on detached retina |
| Applicant | Airgas Therapeutics, LLC |
| Owner/operator | Airgas Therapeutics LLC |
| Product code | LPO |
| Approval date | Feb 25, 1993 |
| Docket number | 93M-0096 |
| Notice date | Apr 14, 1993 |
| Establishment registration | 2518435 |
| FEI number | 2518435 |
At a glance
- 1–9 Supplements
- Jan 20, 2012 Latest supplement decision
- No Withdrawn
- No 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: