Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear
FDA premarket approval P080011/S116 · decided 2020-09-21
Approval details
- PMA number
- P080011
- Supplement
- S116
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2020-08-24
- Decision date
- 2020-09-21
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- Introduction of an additional MTO (Made To Order) collation and packaging machine for the Biofinity XR Toric and Biofinity Toric Multifocal (comfilcon A) soft (hydrophilic) contact lenses for extended wear at the CooperVision Manufacturing, Ltd. facility in Hamble, United Kingdom
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