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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.
 
DevicePMMA INTAOCULAR LENS
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantBausch & Lomb, Inc.
50 Technology
Irvine, CA 92618
PMA NumberP840039
Supplement NumberS050
Date Received04/08/2002
Decision Date05/21/2002
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Express GMP Supplement
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A NEW MANUFACTURING FACILITY LOCATED AT BAUSCH & LOMB, INC. WILMINGTON, MASSACHUSETTS. THE CLEAR COMPRESSION MOLDED BLANK PMMA MATERIAL WILL BE MANUFACTURED AT THIS FACILITY.
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