AquaClear Premium
FDA premarket approval P080011/S067 · decided 2018-04-09
Approval details
- PMA number
- P080011
- Supplement
- S067
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- AquaClear Premium
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2017-12-26
- Decision date
- 2018-04-09
- Days to decision
- 104 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- Approval for the addition of a new private label brand name, AquaClear Premium.
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