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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
Generic NameAID, SURGICAL, VISCOELASTIC
Regulation Number886.4275
ApplicantAlcon Laboratories
6201 S. Fwy.
Fort Worth, TX 76134
PMA NumberP840064
Supplement NumberS017
Date Received12/26/1995
Decision Date06/21/1996
Product Code LZP 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
1)USE OF ALTERNATE STERILIZATION PROCESS USING 100% ETHYLENE OXIDE (ETO)/NITROGEN PURGE BY THE CONTRACT STERILIZER, STERI-TECH, INC. OF SALINAS, PUERTO RICO; 2)SHELF LIFE OF 24 MONTHS FOR VISCOAT AND 36 MONTHS FOR PROVISC; 3) ALTERNATE PACKAGING FOR PROVISC
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