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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namefluid, intraocular
Generic Namefluid, intraocular
Regulation Number886.4275
6201 south freeway r3-48
fort worth, TX 76134
PMA NumberP950018
Supplement NumberS002
Date Received02/11/1999
Decision Date03/05/1999
Product Code
LWL[ Registered Establishments with LWL ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the following changes: use of an alternate Fluorotec S2-F451W stopper; changes in the aseptic filling and packaging processes to use the CBL Autobloc automated filling line; an alternate fill volume (2 ml) for Perfluoron in a unit package; a new Master Batch Record for the automated filling line which includes 2 ml, 5 ml and 7 ml fill volumes and a lot size increase to a maximum of 9,000 vials per lot; secondary packaging configurations designed to provide a vial (5ml or 7ml) in a unit package without other kit components as well as in as accessory kit; and the kit components provided as a stand-alone accessory kit.