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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.
 
DeviceTECNIS ACRYLIC IOL
Classification Nameintraocular lens
Generic Nameintraocular lens
Regulation Number886.3600
Applicant
ABBOTT MEDICAL OPTICS INC
1700 e. st. andrew place
santa ana, CA 92705
PMA NumberP990080
Supplement NumberS031
Date Received08/29/2008
Decision Date09/30/2008
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
CHANGE IN THE SHEET CASTING PROCESS FOR MANUFACTURING THE DEVICE.
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