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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 NameAMO(R) VITRAX(R) VISCOELASTIC SOLUTION
Classification Nameaid, surgical, viscoelastic
Regulation Number886.4275
ApplicantALLERGAN MEDICAL OPTICS
PMA NumberP880031
Supplement NumberS009
Date Received10/17/1995
Decision Date04/09/1996
Product Code
LZP[ Registered Establishments with LZP ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason location change: sterilizer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
New sterilization site at griffith micro science in glen falls, new york and a new sterilization process, 100% ethylene oxide, for amo vitrax (sodium hyaluronate) in final packaging.
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