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 | SOFTLENS66 TORIC (ALPHAFILCON A) VISIBILITY TINTED CONTACT LENS |
Generic Name | Lenses, soft contact, extended wear |
Applicant | Bausch & Lomb, Inc. 1400 NORTH GOODMAN ST. ROCHESTER, NY 14609-3547 |
PMA Number | P960022 |
Supplement Number | S004 |
Date Received | 02/06/2004 |
Decision Date | 03/04/2004 |
Product Codes |
LPL LPM |
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 ADDITION OF AN AUTOMATED INSPECTION PROCESS FOR THE SOFTLENS66. |
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