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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.
 
DeviceCHIROFLEX(TM)MODEL C10UB ULTRAVIOLET-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantBausch & Lomb, Inc.
1400 N. Goodman St.
Rochester, NY 14609
PMA NumberP910058
Supplement NumberS008
Date Received12/01/1995
Decision Date01/02/1996
Withdrawal Date09/17/2010
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR ALLERGAN MEDICAL OPTICS TO DISTRIBUTE YOUR CHIROFLEX MODEL C1OUB ULTRAVIOLET-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS AS THE AMO SINGLFLEX MODEL SI-14PB ULTRAVIOLET-ABSORBING SILICONE POSTERIOR CHAMBER IOL
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