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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.
 
Trade NameBVI 1% OVD-SODIUM HYALURONATE VISCOELASTIC
Classification Nameaid, surgical, viscoelastic
Generic Nameviscoelastic opthalmo-surgical aid agent
Regulation Number886.4275
ApplicantFERRING PHARMACEUTICALS, INC.
PMA NumberP960011
Supplement NumberS018
Date Received02/10/2011
Decision Date03/08/2011
Product Code
LZP[ Registered Establishments with LZP ]
Advisory Committee Ophthalmic
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the inclusion of directions for proper finger flange orientation in the instructions for use. In additional approval to change the trade name of the device from bd 1% ovd sodium hyaluronate to bvi 1% ovd sodium hyaluronate.
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