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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 INTRAOCULAR LENSES
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantBausch & Lomb
1400 N. Goodman St.
Rochester, NY 14609
PMA NumberP860002
Supplement NumberS017
Date Received12/19/1995
Decision Date06/05/1996
Withdrawal Date11/26/2008
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 FROM (+4.0 D) - (+34 D) TO (-18.0 D) - (+45 D)
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