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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 NameRIGID GAS PERMEABLE CONTACT LENSES (BOSTON ORTHOKERATOLOGY)
Classification Namelens, contact, orthokeratology, overnight
Generic Nameoprifocon a rigid gas permeable contact lenses
Regulation Number886.5916
ApplicantBAUSCH & LOMB
PMA NumberP010062
Supplement NumberS004
Date Received01/27/2006
Decision Date05/30/2006
Product Code
NUU[ Registered Establishments with NUU ]
Advisory Committee Ophthalmic
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of a cold oxygen plasma treatment step to the current manufacturing process for the boston equalens (itafluorofocon a), boston equalens ii, and boston orthokeratology (oprifocon a) shaping lens.
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