Vitreon(R)
FDA premarket approval P910068 · Fluid, intraocular
PMA numberP910068
Approval
- Applicant
- Air Products & Chemicals, Inc.
- Received
- December 6, 1991
- Decision date
- September 30, 1997 (APWD)
- Supplements
- 1, latest April 4, 2001
- Product code
- LWL – Fluid, Intraocular
Approval order 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 single batch (Batch #672-45-0001) of the finished product packaged in sterile 6 mL vials.