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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.
 
DeviceIPAFLUOROFOCON A AND B
Generic NameLens, contact (other material) - daily
Regulation Number886.5916
ApplicantBausch & Lomb
1400 N Goodman St.
Rochester, NY 14692
PMA NumberP860022
Supplement NumberS050
Date Received02/20/1998
Decision Date03/31/1998
Product Code HQD 
Advisory Committee Ophthalmic
Supplement Type 30-Day Supplement
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the three additional finishing laboratories listed to become additional manufacturers and distributors of the device:Premier Contact Lens, 111 28th Avenue South, Nashville, TN 37212 and Premier Contact Lens, 3614 S.Perkins, Memphis, TN 38118.
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