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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.
 
DeviceOPHTHALMICS- ANIKAVISC, OPTIVISC AND NUVISC
Generic NameAID, SURGICAL, VISCOELASTIC
Regulation Number886.4275
ApplicantAnika Therapeutics, Inc.
32 Wiggins Ave.
Beford, MA 01730
PMA NumberP000046
Supplement NumberS025
Date Received06/10/2014
Decision Date07/08/2014
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  
CHANGE TO THE SYRINGE RESIDUAL SOLVENT TESTING FROM A SUPPLIERS CONTRACT LABORATORY TO THE SUPPLIERS IN-HOUSE FACILITY FOR ANIKAS OPHTHALMIC DEVICES.
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