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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 BAUSH & 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 NumberS002
Date Received09/01/2004
Decision Date12/03/2004
Product Code
NUU[ Registered Establishments with NUU ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
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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