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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 SYSTEM
Classification Nameaid, surgical, viscoelastic
Generic Nameelastic system
Regulation Number886.4275
ApplicantALCON LABORATORIES
PMA NumberP840064
Supplement NumberS015
Date Received08/14/1995
Decision Date03/22/1996
Product Code
LZP[ Registered Establishments with LZP ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for: 1)alternate manufacturing site at puurs, belgium; 2)use of 100% ethylene oxide in the sterilization process; and 3)increase in the allowable fill volume to 0. 75 ml (this was inadvertently not included in our approvable letter of 13-feb-96).
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