up&up Monthly Performance, up&up Monthly Performance XR, up&up Monthly Performance for Astigmatism, up&up Monthly Perfor
FDA premarket approval P080011/S180 · decided 2025-07-23
Approval details
- PMA number
- P080011
- Supplement
- S180
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- up&up Monthly Performance, up&up Monthly Performance XR, up&up Monthly Performance for Astigmatism, up&up Monthly Perfor
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2025-01-27
- Decision date
- 2025-07-23
- Days to decision
- 177 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- 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)
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.