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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 ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS
Generic NameLens, contact, orthokeratology, overnight
ApplicantBausch & Lomb
1400 N. Goodman St.
Rochester, NY 14603
PMA NumberP010062
Supplement NumberS008
Date Received10/20/2010
Decision Date07/28/2014
Product Codes NUU MWL 
Advisory Committee Ophthalmic
Clinical TrialsNCT01272271
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A LABELING UPDATE TO THE PACKAGE INSERT AND PATIENT INFORMATION BOOKLET TO INCLUDE THE RESULTS FROM A SECTION 522 POSTMARKET SURVEILLANCE STUDY (PAS).
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