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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 NumberS011
Date Received12/26/1995
Decision Date04/09/1997
Product Code
LZP[ Registered Establishments with LZP ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternate manufacturing site at allergan botox, ltd. , westport, county mayo, ireland; an alternate contract sterilization facility, isotron ireland, ltd. , tullamore, county offaly, ireland; and an 18 month shelf life.
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