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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.
 
DeviceHEALON D
Generic NameAID, SURGICAL, VISCOELASTIC
Regulation Number886.4275
ApplicantAbbott Medical Optics, Inc.
1700 E. St. Andrew Pl.
Santa Ana, CA 92705
PMA NumberP880031
Supplement NumberS014
Date Received02/15/2007
Decision Date08/22/2008
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  
APPROVAL TO MOVE THE MANUFACTURE OF VITRAX FROM THE ALLERGAN FACILITY IN WESTPORT, IRELAND TO THE AMO UPPSALA FACILITY IN SWEDEN, FOR A 0.4 ML FILL VOLUME IN ADDITION TO THE CURRENTLY APPROVED 0.65 ML FILL VOLUME, AND RE-BRAND THE DISPERSIVE VITRAX PRODUCT MANUFACTURED IN UPPSALA, SWEDEN AS HEALON D (DISPERSIVE).
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