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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 D SODIUM HYALURONATE SOLUTION
Generic NameAID, SURGICAL, VISCOELASTIC
Regulation Number886.4275
ApplicantAbbott Medical Optics, Inc.
1700 E. St. Andrew Pl.
Santa Ana, CA 92705
PMA NumberP880031
Supplement NumberS016
Date Received01/08/2009
Decision Date02/18/2009
Withdrawal Date03/03/2011
Product Code LZP 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO CHANGE THE PH PRODUCT SPECIFICATION RANGE FOR HEALON D FROM 7.1 ¿ 7.5 TO 6.8 ¿ 7.6.
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