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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.
 
DeviceCELLUGEL
Classification Nameaid, surgical, viscoelastic
Generic Nameaid, surgical, viscoelastic
Regulation Number886.4275
Applicant
ALCON LABORATORIES
6201 south freeway
fort worth, TX 76134
PMA NumberP990023
Supplement NumberS011
Date Received04/19/2011
Decision Date05/18/2011
Product Code
LZP[ Registered Establishments with LZP ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Expand the electronic batch record system to include electronic documentation of the reactor/vessel cleaning for ophthalmic viscosurgical devices.
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