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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD)- HEALON5
Generic NameAID, SURGICAL, VISCOELASTIC
Regulation Number886.4275
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP810031
Supplement NumberS054
Date Received06/11/2015
Decision Date08/25/2015
Product Code LZP 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO UPDATE THE LABELING FOR THE HEALON5® OPHTHALMIC VISCOSURGICALDEVICE (OVD) TO REMOVE THE PHYSICIAN TRAINING PROGRAM FOR NEW USERS AND TO REVISE THE PRECAUTIONS SECTION OF THE DIRECTIONS FOR USE TO ALLOW FOR OTHER OVD REMOVAL TECHNIQUES.
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