Biofinity (comfilcon A) Toric Multifocal Soft (Hydrophilic) Extended Wear Contact Lenses
FDA premarket approval P080011/S100 · decided 2019-12-17
Approval details
- PMA number
- P080011
- Supplement
- S100
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Biofinity (comfilcon A) Toric Multifocal Soft (Hydrophilic) Extended Wear Contact Lenses
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2019-09-30
- Decision date
- 2019-12-17
- Days to decision
- 78 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 lens design, toric multifocal, for the Biofinity (comfilcon A) Soft (hydrophilic) Extended Wear Contact Lenses.
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