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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 VISCOELASTIC
Classification Nameaid, surgical, viscoelastic
Regulation Number886.4275
ApplicantADVANCED MEDICAL OPTICS, INC.
PMA NumberP810031
Supplement NumberS033
Date Received12/11/2006
Decision Date08/30/2007
Product Code
LZP[ Registered Establishments with LZP ]
Advisory Committee Ophthalmic
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a different release agent to be used with their existing petg material in the outer blister tray for the secondary packaging of all of the healon ophthalmic viscoelastic products. The device, as modified, will be marketed under the trade names: healon, healon gv and healon5 sodium hyaluronate and is intended to be introduced into the eye to aid performance of surgery, such as to maintain anterior chamber depth, preserve tissue integrity, protect tissue from surgical trauma, or function as a tamponade during retinal reattachment.
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