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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.
 
DeviceAMO(R) VITRAX(R) VISCOELASTIC SOLUTION
Classification Nameaid, surgical, viscoelastic
Generic Nameaid, surgical, viscoelastic
Regulation Number886.4275
Applicant
ABBOTT MEDICAL OPTICS INC
1700 e. st. andrew place
santa ana, CA 92705
PMA NumberP880031
Supplement NumberS011
Date Received12/26/1995
Decision Date04/09/1997
Product Code
LZP[ Registered Establishments with LZP ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternate manufacturing site at allergan botox, ltd. , westport, county mayo, ireland; an alternate contract sterilization facility, isotron ireland, ltd. , tullamore, county offaly, ireland; and an 18 month shelf life.
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