VITREON(R)
FDA premarket approval P910068 · decided 1997-09-30
Approval details
- PMA number
- P910068
- Trade name
- VITREON(R)
- Generic name
- Fluid, intraocular
- Applicant
- Air Products & Chemicals, Inc.
- Date received
- 1991-12-06
- Decision date
- 1997-09-30
- Days to decision
- 2125 days
- Decision code
- APWD
- Product code
- LWL
- Advisory committee
- Ophthalmic
- Expedited review
- Yes
- Location
- Allentown, PA
- Statement
- Approval for VITREON(R) (Perfluorophenanthrene) Intraocular Fluid. This device is indicated for use as an intraoperative surgical aid during vitreoretinal surgery inpatients with primary and recurrent complicated reinal detachments. Complicated cases include giant retinal tear or retinal dialysis, proliferative vitreoretinopathy, proliferative diabetic reinopathy, tractional retinal detachments, and blunt or penetrating ocular trauma. We are pleased to inform you that the PMA is approved for a s
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| COPPER KETTLE VAPORIZER PLUS (K771150) | Air Products & Chemicals, Inc. | 1977-08-04 |
| ANESTHESIA BREATHING CIRCUIT (K771134) | Air Products & Chemicals, Inc. | 1977-07-05 |