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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 FOR OVERNIGHT WEAR FOR BAUSH & LOMB VISION SHAPING TREATMENT
Generic NameLens, contact, orthokeratology, overnight
Regulation Number886.5916
ApplicantBausch & Lomb
1400 N. Goodman St.
Rochester, NY 14603
PMA NumberP010062
Supplement NumberS002
Date Received09/01/2004
Decision Date12/03/2004
Product Code NUU 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO REVISE THE PROFESSIONAL FITTING AND INFORMATION GUIDE PRODUCT LABELING TO INCLUDE FITTING GUIDELINES FOR CORNEAL TOPOGRAPHY-BASED FITTING METHODS AND OTHER MINOR CHANGES AND GRAMMATICAL CORRECTIONS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME REFERENCED ABOVE WITH THE SAME PRIOR APPROVED INDICATIONS FOR USE.
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