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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(R) SODIUM HYALURONATE
Generic NameAID, SURGICAL, VISCOELASTIC
Regulation Number886.4275
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Drive
suite 200
Irvine, CA 92618
PMA NumberP810031
Supplement NumberS022
Date Received09/20/1999
Decision Date12/21/1999
Product Code LZP 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a modification to the final product release testing requirements for the family of Healon(R) Sodium Hyaluronate viscoelastic products.
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