| 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 | up&up Monthly Performance, up&up Monthly Performance XR, up&up Monthly Performance for Astigmatism, up&up Monthly Perfor |
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| Generic Name | Lenses, soft contact, extended wear |
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| Regulation Number | 886.5925 |
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| Applicant | CooperVision, Inc.
6101 Bollinger Canyon Rd.
Suite 500
San Ramon, CA 94583 |
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| PMA Number | P080011 |
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| Supplement Number | S180 |
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| Date Received | 01/27/2025 |
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| Decision Date | 07/23/2025 |
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| Product Code |
LPM |
| Advisory Committee |
Ophthalmic |
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| Supplement Type | Normal 180 Day Track No User Fee |
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| Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
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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 trade name change for CooperVision comfilcon A soft (hydrophilic) contact lenses for extended wear to add up&up Monthly Performance (intended for the spherical lens design), up&up Monthly Performance XR (intended for the extended range “XR” powers of the spherical lens design), up&up Monthly Performance for Astigmatism (intended for the toric lens design), and up&up Monthly Performance Multifocal (intended for the multifocal lens design) |
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