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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 OPTHALMIC VISCOSURGICAL DEVICE
Generic NameAID, SURGICAL, VISCOELASTIC
Regulation Number886.4275
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP110007
Supplement NumberS006
Date Received02/18/2015
Decision Date04/02/2015
Product Code LZP 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
MODIFY THE QUALITY CONTROL TEST METHODS AND/OR ACCEPTANCE CRITERIA ASSOCIATED WITH THE ABBOTT MEDICAL OPTICS (AMO) SODIUM HAYALURONATE (NAHY) SPECIFICATIONS.
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