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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.
 
DeviceSHELLGEL(TM) SODIUM HYALURONATE
Generic NameAID, SURGICAL, VISCOELASTIC
Regulation Number886.4275
ApplicantAnika Therapeutics, Inc.
32 WIGGINS AVENUE
BEDFORD, MA 01730
PMA NumberP000046
Supplement NumberS001
Date Received05/10/2001
Decision Date06/11/2001
Product Code LZP 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A PRIVATE DISTRIBUTOR AGREEMENT WITH CYTOSOL OPHTHALMICS, INC. THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME SHELLGEL(TM) SODIUM HYALURONATE.
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