| Note: 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. |
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| Device | VITREON(R) |
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| Generic Name | Fluid, intraocular |
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| Regulation Number | 886.4275 |
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| Applicant | AIR PRODUCTS & CHEMICALS, INC.
7201 HAMILTON BLVD.
ALLENTOWN, PA 18951-501 |
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| PMA Number | P910068 |
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| Date Received | 12/06/1991 |
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| Decision Date | 09/30/1997 |
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|
Withdrawal Date
|
06/27/2003 |
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| Product Code |
LWL |
| Docket Number | 97M-0519 |
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| Notice Date | 01/02/1998 |
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| Advisory Committee |
Ophthalmic |
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| Expedited Review Granted? | Yes |
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| Combination Product | No |
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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. |
| Supplements: |
S001 |
|
|
