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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameSTAARVISC II,SHELLGEL AND COEASE VISCOELASTICS
Classification Nameaid, surgical, viscoelastic
Regulation Number886.4275
ApplicantANIKA THERAPEUTICS, INC.
PMA NumberP000046
Supplement NumberS004
Date Received05/21/2002
Decision Date12/03/2002
Product Code
LZP[ Registered Establishments with LZP ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a buffered formulation (ph 6. 8 - 7. 6) for staarvisc ii, shellgel, and coease viscoelastics.
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