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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameHEALON ENDOCOAT OPVISCOSURGICAL OPHTHALMIC DEVICE (OVD) (3% SODIUM HYALURONATE)
Classification Nameaid, surgical, viscoelastic
Regulation Number886.4275
ApplicantABBOTT MEDICAL OPTICS INC
PMA NumberP110007
Date Received02/22/2011
Decision Date07/02/2012
Product Code
LZP[ Registered Establishments with LZP ]
Docket Number 12M-0734
Notice Date 07/16/2012
Advisory Committee Ophthalmic
Clinical Trials NCT00972621
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the healon endocoat ovd. Healon endocoat ovd is an ophthalmic viscoelastic containing 3% sodium hyaluronate indicated for use as a surgical aid in patients undergoing ophthalmic anterior segment surgical procedures including, cataract surgery with an intraocular lens, cataract surgery without an intraocular lens, and secondary intraocular lens implantation. Healon endocoat ovd maintains a deep chamber during anterior segment surgery, enhances visualization during the surgical procedure and protects the corneal endothelium and other ocular tissue. The viscoelasticity of the solution maintains the normal position of the vitreous face and prevents formation of a flat chamber during surgery. It may also be used to coat intraocular lenses and insertion instruments prior to intraocular lens implantation.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 
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