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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
Classification Namefluid, intraocular
Generic Namefluid, intraocular
Regulation Number886.4275
7201 hamilton blvd.
allentown, PA 18951-501
PMA NumberP910068
Date Received12/06/1991
Decision Date09/30/1997
Withdrawal Date 06/27/2003
Product Code
LWL[ Registered Establishments with LWL ]
Docket Number 97M-0519
Notice Date 01/02/1998
Advisory Committee Ophthalmic
Expedited Review Granted? Yes
Combination Product No
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