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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 & HEALON5 SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES
Classification Nameaid, surgical, viscoelastic
Regulation Number886.4275
ApplicantADVANCED MEDICAL OPTICS, INC.
PMA NumberP810031
Supplement NumberS035
Date Received01/30/2008
Decision Date08/01/2008
Product Code
LZP[ Registered Establishments with LZP ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track no user fee
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a new contract sterilizer for secondary packaging.
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