| 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 | DURASOFT 3 (PHEMFILCON A) UV OPTIFIT TORIC (HYDROPHILLIC) CONTACT LENSES |
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| Generic Name | Lenses, soft contact, extended wear |
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| Regulation Number | 886.5925 |
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| Applicant | Alcon Laboratories, Inc.
6201 S. Fwy.
Fort Worth, TX 76134 |
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| PMA Number | P830037 |
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| Supplement Number | S041 |
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| Date Received | 07/06/1998 |
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| Decision Date | 05/20/1999 |
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| Withdrawal Date | 02/27/2019 |
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| Product Code |
LPM |
| Advisory Committee |
Ophthalmic |
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| Supplement Type | Normal 180 Day Track |
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| Supplement Reason | Change Design/Components/Specifications/Material |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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Approval Order Statement
Approval for the DuraSoft(R) 3 UV (phemfilcon A) Spherical and Optifit Toric Clear, Handling Tint, Colors, and Color Complements Soft (hydrophilic) Contact Lens (lathe cut) for Extended Wear to incorporate the pigment carbazole violet as a handling tint at Wesley Jessen - Cidra Operation, Road 173, KM 1.1, Cidra, PR 00739. The pigment will be incorporated as an in-monomer tint by entrapment. |
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