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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 NameHEALON D
Classification Nameaid, surgical, viscoelastic
Generic Nameviscoelastic solution
Regulation Number886.4275
ApplicantADVANCED MEDICAL OPTICS, INC.
PMA NumberP880031
Supplement NumberS014
Date Received02/15/2007
Decision Date08/22/2008
Product Code
LZP[ Registered Establishments with LZP ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
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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