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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(R) VITRAX(R) VISCOELASTIC SOLUTION
Generic NameAID, SURGICAL, VISCOELASTIC
Regulation Number886.4275
ApplicantABBOTT MEDICAL OPTICS INC
1700 E. St. Andrew Place
Santa Ana, CA 92705
PMA NumberP880031
Supplement NumberS012
Date Received02/02/1998
Decision Date02/19/1998
Withdrawal Date 03/03/2011
Product Code LZP 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a modification to final product release testing requirements for AMO(R) VITRAX(R).
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