This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
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.
| Device | VITREON(R) |
| Generic Name | Fluid, Intraocular |
| Applicant | AIR PRODUCTS & CHEMICALS, INC. |
| Date Received | 1991-12-06 |
| Decision Date | 1997-09-30 |
| Notice Date | 1998-01-02 |
| PMA | P910068 |
| Supplement | S |
| Product Code | LWL |
| Docket Number | 97M-0519 |
| Advisory Committee | Ophthalmic |
| Expedited Review | Yes |
| Combination Product | No |
| Applicant Address | AIR PRODUCTS & CHEMICALS, INC. 7201 Hamilton Blvd. allentown, PA 18951-501 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P910068 | Original Filing | |
| S001 | 1999-04-26 | Normal 180 Day Track |