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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(R) RXD(TM)(ITABISFLUOROFOCON A) BIFOCAL LEN
Generic NameLens, contact (other material) - daily
Regulation Number886.5916
ApplicantBAUSCH & LOMB
1400 N. GOODMAN ST.
ROCHESTER, NY 14692
PMA NumberP860022
Supplement NumberS038
Date Received01/16/1992
Decision Date02/20/1992
Product Code HQD 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
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