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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.
 
DeviceOCUCOAT OPHTHALMIC VISCOSURGICAL DEVICE
Generic NameAID, SURGICAL, VISCOELASTIC
Regulation Number886.4275
ApplicantBausch & Lomb, Inc.
50 Technology Dr.
Irvine, CA 92618
PMA NumberP860047
Supplement NumberS031
Date Received07/01/2015
Decision Date09/25/2015
Product Code LZP 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO CHANGE THE CANNULA ON THE 1 ML OCUCOAT 2% HYDROXYPROPYLMETHYLCELLULOSE OPHTHALMIC SURGICAL DEVICE TO A 25 GAUGE NEEDLE WITH A 32 DEGREE BEND.
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