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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 HEALON ENDOCOAT OPHTHALMIC VISCOSURGICAL DEVICE (OVD),(3% SODIUM HYALURONATE)
Classification Nameaid, surgical, viscoelastic
Regulation Number886.4275
ApplicantABBOTTMED
PMA NumberP110007
Supplement NumberS005
Date Received05/28/2013
Decision Date06/27/2013
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 No
Approval Order Statement 
Conversion of an existing clean room space into an additional formulation room for the use in the production of the healon endocoat ovd.
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