Natural Eyes HydraWear XW Extended Parameters, Natural Eyes HydraWear XW for Astigmatism Extended Parameters
FDA premarket approval P080011/S142 · decided 2022-08-15
Approval details
- PMA number
- P080011
- Supplement
- S142
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Natural Eyes HydraWear XW Extended Parameters, Natural Eyes HydraWear XW for Astigmatism Extended Parameters
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2022-03-24
- Decision date
- 2022-08-15
- Days to decision
- 144 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 Natural Eyes HydraWear XW Extended Parameters and Natural Eyes HydraWear XW for Astigmatism Extended Parameters.
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