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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 NamePROVISC OPHTHALMIC VISCOSURGICAL DEVICE, PROVISC PACKAGED IN DUOVISC VISCOELASTIC SYSTEM AND DISCOVISC OPHTHALMIC VISCO
Classification Nameaid, surgical, viscoelastic
Generic Namesterile viscoelastric material
Regulation Number886.4275
ApplicantALCON LABORATORIES
PMA NumberP840064
Supplement NumberS028
Date Received07/06/2005
Decision Date07/29/2005
Product Code
LZP[ Registered Establishments with LZP ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Change in the bacterial master seed storage media used by the vendor.
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