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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 NameVISCOAT VISCOELASTIC SOLUTION
Classification Nameaid, surgical, viscoelastic
Generic Namesodium hyaluronate
Regulation Number886.4275
ApplicantALCON LABORATORIES
PMA NumberP840064
Supplement NumberS017
Date Received12/26/1995
Decision Date06/21/1996
Product Code
LZP[ Registered Establishments with LZP ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product Yes
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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