Ethos AquaTech Monthly XR, Ethos AquaTech Monthly XR for Astigmatism
FDA premarket approval P080011/S141 · decided 2022-09-19
Approval details
- PMA number
- P080011
- Supplement
- S141
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Ethos AquaTech Monthly XR, Ethos AquaTech Monthly XR for Astigmatism
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2022-03-23
- Decision date
- 2022-09-19
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- Approval for the following new private label brand names: Ethos AquaTech Monthly XR and Ethos AquaTech Monthly XR for astigmatism
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