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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 HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES
Classification Nameaid, surgical, viscoelastic
Regulation Number886.4275
ApplicantADVANCED MEDICAL OPTICS, INC.
PMA NumberP810031
Supplement NumberS027
Date Received04/13/2006
Decision Date08/28/2006
Product Code
LZP[ Registered Establishments with LZP ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a new secondary packaging configuration for the healon, healongv and healon5 sodium hyaluronate ophthalmic viscoelastic devices.
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