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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.
 
DeviceVISCOAT VISCOELASTIC SOLUTION
Classification Nameaid, surgical, viscoelastic
Generic Nameaid, surgical, viscoelastic
Regulation Number886.4275
Applicant
ALCON LABORATORIES
6201 s freeway
ft worth, TX 76134
PMA NumberP840064
Supplement NumberS019
Date Received12/04/1996
Decision Date03/17/1998
Product Code
LZP[ Registered Establishments with LZP ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
APPROVAL FOR THE INCORPORATION OF VISCOAT AND PROVISC, WHICH MAKE UP THE DUOVISC PRODUCT, INTO A SINGLE PLASTIC TRAY, TO BE STERILIZED AND PROCESSED AT ALCON'S PUERTO RICO FACILITY; AND A CHANGE IN THE STERILIZATION PROCESS AT ALCON'S PUERTO RICO FACILITY FOR THE DUOVISC SYSTEM.
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