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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, HEALON GV AND HEALON5 SODIUM HYLAURONATE OPHTHALMIC VISCOELASTIC DEVICES
Classification Nameaid, surgical, viscoelastic
Regulation Number886.4275
ApplicantADVANCED MEDICAL OPTICS, INC.
PMA NumberP810031
Supplement NumberS031
Date Received10/03/2006
Decision Date08/16/2007
Product Code
LZP[ Registered Establishments with LZP ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the transfer and expansion of the quality control microbiology laboratory used for the healon, healon gv and healon5 sodium hyaluronate ophthalmic viscoelastic devices. The transfer includes test methods, personnel, and equipment from building 16 to building 23 located in uppsala, sweden.
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