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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 NameBD 1% OVD (1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID)
Classification Nameaid, surgical, viscoelastic
Generic Nameviscoelastic opthalmo-surgical aid agent
Regulation Number886.4275
ApplicantFERRING PHARMACEUTICALS, INC.
PMA NumberP960011
Supplement NumberS015
Date Received12/08/2009
Decision Date01/07/2010
Product Code
LZP[ Registered Establishments with LZP ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in the layout of the manufacturing facility and relocation of the dissolution vessel and microfiltration system.
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