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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.
 
DeviceBOSTON EQUALENS(ITAFLUOROFOCON A)/EQUALENS II(OPRIFOCON A)
Generic NameLens, contact (other material) - daily
Regulation Number886.5916
ApplicantBausch & Lomb
1400 N Goodman St.
Rochester, NY 14692
PMA NumberP860022
Supplement NumberS052
Date Received01/05/2000
Decision Date02/04/2000
Product Code HQD 
Advisory Committee Ophthalmic
Supplement Type 30-Day Supplement
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval under a 30-day notice for addition of one finishing laboratory, Procornea Nederland BV, Kollergan9, NL-6961 LZ Eerbeek, The Netherlands, to become an additional manufacturing and distributino site for the referenced devices.
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