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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.
 
DeviceCHAMBER LENS MODELS 101, 101B, 101T
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantBausch & Lomb
1400 N. Goodman St.
Rochester, NY 14609
PMA NumberP790027
Supplement NumberS037
Date Received08/22/1988
Decision Date10/03/1988
Withdrawal Date11/26/2008
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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