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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 SYRINGE PRODUCT
Generic NameAID, SURGICAL, VISCOELASTIC
Regulation Number886.4275
ApplicantBausch & Lomb, Inc.
50 Technology Drive
Irvine, CA 92618
PMA NumberP860047
Supplement NumberS025
Date Received11/18/2010
Decision Date02/03/2012
Product Code LZP 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR AN ALTERNATE ELASTOMERIC TIP CAP MATERIAL (FM27) AND THE ADDITION OF A THREADED PLASTIC RIGID TIP CAP (PRTC) OUTER SHELL.
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