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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.
 
DeviceABBOTT MEDICAL OPTICS (AMO) HEALON ENDOCOAT OPHTHALMIC VISCOSURGICAL DEVICE
Generic NameAID, SURGICAL, VISCOELASTIC
Regulation Number886.4275
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Drive
Suite 200
Irvine, CA 92618
PMA NumberP110007
Supplement NumberS001
Date Received09/12/2012
Decision Date10/09/2012
Product Code LZP 
Advisory Committee Ophthalmic
Clinical TrialsNCT00972621
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
CHANGE FROM A MANUAL TO AN AUTOMATED PROCESS FOR THE SYRINGE AND CARTON ASSEMBLIES.
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