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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 NameAMO(R) VITRAX(R) VISCOELASTIC SOLUTION
Classification Nameaid, surgical, viscoelastic
Regulation Number886.4275
ApplicantALLERGAN MEDICAL OPTICS
PMA NumberP880031
Supplement NumberS012
Date Received02/02/1998
Decision Date02/19/1998
Product Code
LZP[ Registered Establishments with LZP ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a modification to final product release testing requirements for amo(r) vitrax(r).
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