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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.
 
DeviceMODEL HSM65 UV ABSORBING PMMA ANTERIOR CHAMBER LENS
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantAbbott Medical Optics, Inc.
1700 E. St. Andrew Pl.
Santa Ana, CA 92705
PMA NumberP880070
Supplement NumberS010
Date Received11/07/2003
Decision Date03/17/2004
Withdrawal Date10/04/2010
Product Code HQL 
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 MATERIAL AND THE MANUFACTURING PROCESS, TO ADD A HEPARIN SURFACE MODIFICATION, AND TO CHANGE THE LENS MODEL DESIGNATION FORM UV65B TO HSM65.
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