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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.
 
DeviceHEALON,HEALON GV, & HEALON5 SODIUM HYALURONATE VISCOELASTIC
Generic NameAID, SURGICAL, VISCOELASTIC
Regulation Number886.4275
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP810031
Supplement NumberS033
Date Received12/11/2006
Decision Date08/30/2007
Product Code LZP 
Advisory Committee Ophthalmic
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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