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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 ENDOCOAT OPHTHALMIC VISCOELASTIC DEVICES (OVD)
Generic NameAID, SURGICAL, VISCOELASTIC
Regulation Number886.4275
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP110007
Supplement NumberS003
Date Received04/01/2013
Decision Date05/28/2013
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 THE USE OF A NEW RAW MATERIAL SUPPLIER FOR THE NUTRIENT SOURCE USED IN THE SODIUM HYALURONATE MANUFACTURING PROCESS.
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