Natural Eyes HydraWear XW Multifocal
FDA premarket approval P080011/S112 · decided 2021-01-07
Approval details
- PMA number
- P080011
- Supplement
- S112
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Natural Eyes HydraWear XW Multifocal
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2020-07-20
- Decision date
- 2021-01-07
- Days to decision
- 171 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- Approval for a new private label trade name, Natural Eyes HydraWear XW Multifocal, for the CooperVision comfilcon A soft (hydrophilic) contact lenses for extended wear.
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