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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.
 
DeviceOPTIVISC
Classification Nameaid, surgical, viscoelastic
Generic Nameaid, surgical, viscoelastic
Regulation Number886.4275
Applicant
Anika Therapeutics, Inc.
32 wiggins avenue
bedford, MA 01730
PMA NumberP000046
Supplement NumberS016
Date Received10/02/2009
Decision Date02/12/2010
Product Code
LZP[ Registered Establishments with LZP ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR REVISIONS TO THE LABELING TO REFLECT A NEW DISTRIBUTOR NAME AND TO CHANGE THE TRADE NAME TO OPTIVISC.
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