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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 NameOCUCOAT
Classification Nameaid, surgical, viscoelastic
Regulation Number886.4275
ApplicantBAUSCH & LOMB, INC.
PMA NumberP860047
Supplement NumberS020
Date Received10/04/2007
Decision Date03/24/2008
Product Code
LZP[ Registered Establishments with LZP ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change to the primary container of ocucoat, packaging and method of sterilization.
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