Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear
FDA premarket approval P080011/S146 · decided 2022-07-25
Approval details
- PMA number
- P080011
- Supplement
- S146
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2022-04-27
- Decision date
- 2022-07-25
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- Approval for the introduction of a new primary packaging foil for Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear.
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