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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.
 
DevicePOSTERIOR CHAMBER INTRAOCULAR LENS
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantBausch & Lomb
1400 N. Goodman St.
Rochester, NY 14609
PMA NumberP790027
Supplement NumberS065
Date Received08/16/1999
Decision Date05/08/2001
Withdrawal Date11/26/2008
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Express GMP Supplement
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE MANUFACTURE OF THE HMWX-PMAA AND CC MII BLANK MATERIALS IN THE PRODUCTION OF PMAA INTRAOCULAR LENSES AT THE BAUSCH & LOMB SURGICAL, CLEARWATER, FLORIDA FACILITY.
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