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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.
 
DeviceONE PIECE POSTERIOR CHAMBER IOL
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantBausch & Lomb, Inc.
50 Technology
Irvine, CA 92618
PMA NumberP840039
Supplement NumberS049
Date Received12/19/1995
Decision Date06/05/1996
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO EXTEND THE POWER RANGE FOR YOUR ONE-PIECE POSTERIOR CHAMBER IOLS FORM (+4.0 D) - (+34 D) TO (-18.0 D) - (+45 D).
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