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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 UV44B INTRAOCULAR LENS
Generic NameLens, contact (other material) - daily
Regulation Number886.5916
ApplicantAbbott Medical Optics, Inc.
1700 E. St. Andrew Pl.
Santa Ana, CA 92705
PMA NumberP880041
Supplement NumberS001
Date Received03/12/1990
Decision Date05/08/1990
Product Code HQD 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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