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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceAMO VITRAX (SODIUM HYALURONATE)
Generic NameAID, SURGICAL, VISCOELASTIC
Regulation Number886.4275
ApplicantAbbott Medical Optics, Inc.
1700 E. St. Andrew Pl.
Santa Ana, CA 92705
PMA NumberP880031
Supplement NumberS010
Date Received11/24/1995
Decision Date04/08/1996
Withdrawal Date03/03/2011
Product Code LZP 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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