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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 NameVITRAX OPHTHALMIC SURGICAL AID
Classification Nameaid, surgical, viscoelastic
Regulation Number886.4275
ApplicantALLERGAN MEDICAL OPTICS
PMA NumberP880031
Supplement NumberS007
Date Received08/21/1992
Decision Date01/10/1994
Product Code
LZP[ Registered Establishments with LZP ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
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