Pearl Vision Monthly (confilcon A) Soft (Hydriohilic) Contact Lenses , Pearle Vision Monthly for Astigmatism (comfilcon
FDA premarket approval P080011/S049 · decided 2017-03-10
Approval details
- PMA number
- P080011
- Supplement
- S049
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Pearl Vision Monthly (confilcon A) Soft (Hydriohilic) Contact Lenses , Pearle Vision Monthly for Astigmatism (comfilcon
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2016-09-27
- Decision date
- 2017-03-10
- Days to decision
- 164 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- Approved for Cooper Vision comfilcon A soft extended wear contact lenses to add a new private label name Pearl Vision Monthly and Pearl Vision Monthly for Astigatism.
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