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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 VITRAX (SODIUM HYALURONATE)
Classification Nameaid, surgical, viscoelastic
Regulation Number886.4275
ApplicantALLERGAN MEDICAL OPTICS
PMA NumberP880031
Supplement NumberS010
Date Received11/24/1995
Decision Date04/08/1996
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
Approval Order Statement 
Use of "pharmaceutical grade" sodium hyaluronate powder supplied by akzo nobel corporation, diosynth bv, kloosterstraat 6, 5349 ab oss, the netherlands, as an alternate supply of sodium hyaluronate powder for use in the manufacture of amo vitrax sodium hyaluronate.
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