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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.
 
DeviceHYDROVIEW COMPOSITE HYDROGEL FOLDABLE ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)
Classification Nameintraocular lens
Generic Nameintraocular lens
Regulation Number886.3600
Applicant
Bausch & Lomb, Inc.
50 technology drive
irvine, CA 92618
PMA NumberP990014
Supplement NumberS001
Date Received04/24/2001
Decision Date10/19/2001
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL TO USE THE SUREFOLD 1.5 PACKAGING FOR THE HYDROVIEW IOL.
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