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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.
 
DeviceBD 1% OVD ( 1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID)
Classification Nameaid, surgical, viscoelastic
Generic Nameaid, surgical, viscoelastic
Regulation Number886.4275
Applicant
FERRING PHARMACEUTICALS, INC.
100 interpace parkway
parsippany, NJ 07054
PMA NumberP960011
Supplement NumberS016
Date Received12/07/2009
Decision Date01/07/2010
Product Code
LZP[ Registered Establishments with LZP ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in a quality control test method for the finished device.
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