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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 NameNUVISC
Classification Nameaid, surgical, viscoelastic
Generic Nameaid,surgical,viscoelastic
Regulation Number886.4275
ApplicantANIKA THERAPEUTICS, INC.
PMA NumberP000046
Supplement NumberS023
Date Received01/15/2014
Decision Date04/10/2014
Product Code
LZP[ Registered Establishments with LZP ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - trade name
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a new trade name. The device, as modified, will be marketed under the trade name nuvisctm and is indicated for use during surgery in the anterior and posterior segments of the human eye. Procedures include: cataract extraction, intraocular lens (iol) implantation, corneal transplantation surgery, glaucoma filtering surgery, and surgical procedures to reattach the retina.
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