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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameBOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS FOR OVERNIGHT WEAR FOR BAUSCH & LOMB VISION SHAPING TREATMENT
Classification Namelens, contact, orthokeratology, overnight
Generic Nameoprifocon a rigid gas permeable contact lenses
Regulation Number886.5916
ApplicantBAUSCH & LOMB
PMA NumberP010062
Supplement NumberS006
Date Received01/31/2008
Decision Date02/21/2008
Product Code
NUU[ Registered Establishments with NUU ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason process change: packaging
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for wet shipping, with storage up to 30 days, of the boston equalens, equalens ii and boston orthokeratology shaping rigid gas permeable contact lenses in boston simplus multi-action solution.
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