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. |
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Device | BOSTON EQUALENS (ITAFLUOROFOCON A) RIGID GAS PERMEABLE CONTACT LENS, EQUALENS 2 (OPRIFOCON A) RIGID GAS PERMEARABLE LENS |
Generic Name | Lens, contact (rigid gas permeable), extended wear |
Regulation Number | 886.5916 |
Applicant | BAUSCH & LOMB 1400 N. GOODMAN ST. ROCHESTER, NY 14692 |
PMA Number | P860022 |
Supplement Number | S057 |
Date Received | 01/31/2008 |
Decision Date | 02/21/2008 |
Product Code |
MWL |
Advisory Committee |
Ophthalmic |
Supplement Type | Real-Time Process |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
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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