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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.
Classification Nameaid, surgical, viscoelastic
Generic Namesterile viscoelastric material
Regulation Number886.4275
PMA NumberP840064
Supplement NumberS025
Date Received02/17/2004
Decision Date03/05/2004
Product Code
LZP[ Registered Establishments with LZP ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval to modify the ph release and stability specification ranges for provisc ophthalmic viscosurgical device contained within the duovisc viscoelastic system from ph 7. 0-7. 3 to ph 7. 0-7. 4 for release and ph 7. 0-7. 5 to ph 6. 8-7. 5 for stability.