Premarket Approval (PMA)

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 Name: BOSTON ORTHOKERATOLOGY SHAPING LENS FOR OVERNIGHT WEAR
• Classification Name: lens, contact, orthokeratology, overnight
• Generic Name: oprifocon a rigid gas permeable contact lenses
• Regulation Number: 886.5916
• Applicant: BAUSCH & LOMB
• PMA Number: P010062
• Supplement Number: S009
• Date Received: 05/31/2011
• Decision Date: 06/22/2011
• Product Code: NUU [ Registered Establishments with NUU ]
• Advisory Committee: Ophthalmic
• Supplement Type: 30-day notice
• Supplement Reason: process change - other
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Alternate supplier of 0. 2 micron formulation filter.