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/EQUALENS II |
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 | S058 |
Date Received | 05/31/2011 |
Decision Date | 06/22/2011 |
Product Code |
MWL |
Advisory Committee |
Ophthalmic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement ALTERNATE SUPPLIER OF 0.2 MICRON FORMULATION FILTER. |
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