Ethos AquaTech Evolve Monthly
FDA premarket approval P080011/S167 · decided 2024-11-15
Approval details
- PMA number
- P080011
- Supplement
- S167
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Ethos AquaTech Evolve Monthly
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2024-06-20
- Decision date
- 2024-11-15
- Days to decision
- 148 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- Approval for a trade name change for CooperVision comfilcon A soft (hydrophilic) contact lenses for extended wear to add Ethos AquaTech Evolve Monthly (intended for the aspherical 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.