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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.
 
DeviceSTAARVISC II, SHELLGEL AND COEASE
Generic NameAID, SURGICAL, VISCOELASTIC
Regulation Number886.4275
ApplicantAnika Therapeutics, Inc.
32 Wiggins Ave.
Beford, MA 01730
PMA NumberP000046
Supplement NumberS008
Date Received04/25/2003
Decision Date05/22/2003
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  
MANUFACTURING CHANGE FOR AN ADDITIONAL PROCESS CONTROL TREATMENT FOR STAARVISC II, SHELLGEL AND COEASE.
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