Identity
- Trade Name
- SULFUR HEXAFLUORIDE FDA PMA
- Generic Name
- Gases used within eye to place pressure on detached retina FDA PMA
Identifiers
- PMA Number
- P900067 FDA PMA
- FDA Product Code
- LPO FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Legislation / Framework
- 21 CFR Part 886.4270 FDA PMA
- Regulation Number
- 886.4270 FDA PMA
- Advisory Committee
- Ophthalmic FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Isopan Sulfur Hexafluoride SF6 Gas is classified as a Gas Used Within Eye to Place Pressure on Detached Retina, an ophthalmic device designed to support retinal reattachment. It is a sterile, non-reactive gas injected into the vitreous cavity to exert tamponade pressure, aiding in the stabilization of retinal detachment until surgical repair can be performed.
This device is supplied as a sterile, single-use gas cylinder for intraocular use under direct ophthalmic supervision. It is regulated under FDA Premarket Approval (PMA P900067) and falls under device classification III (LPO product code). Storage requires protection from extreme temperatures and light, adhering to standard ophthalmic gas handling protocols.
Frequently asked questions
What is the primary clinical purpose of the Isopan Sulfur Hexafluoride SF6 Gas in ophthalmology?
The Isopan Sulfur Hexafluoride SF6 Gas is designed to exert tamponade pressure inside the eye’s vitreous cavity. This helps stabilize a detached retina by physically supporting it until surgical reattachment can be performed, effectively acting as a temporary internal brace.
Is this device intended for repeated use in the same patient, or is it meant for single-use only?
This device is explicitly labeled as a single-use gas cylinder. Once injected into the vitreous cavity under direct ophthalmic supervision, it is not intended for reuse or removal, aligning with standard sterile, intraocular gas protocols.
How should the Isopan Sulfur Hexafluoride SF6 Gas be stored to maintain its integrity?
Storage requires protection from extreme temperatures and light, following standard ophthalmic gas handling protocols. This ensures the gas remains stable and effective for its intended clinical use.
What regulatory pathway does this device follow, and how does that affect its availability?
The Isopan Sulfur Hexafluoride SF6 Gas is regulated under FDA Premarket Approval (PMA P900067), meaning its use is authorized through a rigorous approval process. This classification (III, LPO product code) ensures it meets strict safety and efficacy standards before clinical deployment.
Are there different sizes or models of this gas cylinder, or is it supplied uniformly?
The provided data does not specify multiple sizes or models—it describes the device as a single standardized sterile gas cylinder for intraocular use. Clinical application relies on the gas’s volume and tamponade properties rather than physical variations in the cylinder itself.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P900067 | Class III | Active |
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Manufacturer
- Manufacturer
- Airgas Therapeutics LLC
- FDA Applicant
- Airgas Therapeutics, LLC
Sources (1)
- FDA PMA P900067 24 fields · synced Sep 18, 2026