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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceHEALON, HEALON GV/HEALON 5 SODIUM HYALURONATE OPHTHALMIC VISCOSURGICAL DEVICES
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 NumberP810031
Supplement NumberS036
Date Received08/20/2008
Decision Date09/19/2008
Product Code
LZP[ Registered Establishments with LZP ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
IMPLEMENTATION OF A NEW WATER SYSTEM.
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