Perfluoropropane for Pneumatic Retinopexy
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- PERFLUOROPROPANE FDA PMA
- Generic Name
- Gases used within eye to place pressure on detached retina FDA PMA
Identifiers
- PMA Number
- P900066 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
Perfluoropropane for Pneumatic Retinopexy is a medical gas used within the eye to place pressure on a detached retina. It is classified as a gas used within the eye to place pressure on detached retina under FDA device class III.
This device is supplied as a sterile, single-use gas for intraocular injection during pneumatic retinopexy procedures. It is authorized under FDA PMA P900066 and intended for use in ophthalmic surgical settings by qualified physicians.
Frequently asked questions
What is Perfluoropropane for Pneumatic Retinopexy used for?
Perfluoropropane for Pneumatic Retinopexy is a medical gas used within the eye to place pressure on a detached retina during pneumatic retinopexy surgery, as defined by its device classification and specifications.
Is Perfluoropropane for Pneumatic Retinopexy a single-use device?
Yes, Perfluoropropane for Pneumatic Retinopexy is supplied as a sterile, single-use gas intended for intraocular injection during ophthalmic procedures, based on its classification as a gas used within the eye to place pressure on detached retina.
What regulatory authorization covers Perfluoropropane for Pneumatic Retinopexy?
Perfluoropropane for Pneumatic Retinopexy is authorized under FDA Premarket Approval (PMA) number P900066, as indicated in the AUTHORIZATIONS and openfda fields of the device data.
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 | P900066 | Class III | Active |
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Manufacturer
- Manufacturer
- Airgas Therapeutics LLC
- FDA Applicant
- Airgas Therapeutics, LLC
Sources (1)
- FDA PMA P900066 24 fields · synced Sep 18, 2026