comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses
FDA premarket approval P080011/S079 · decided 2019-03-08
Approval details
- PMA number
- P080011
- Supplement
- S079
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2018-08-09
- Decision date
- 2019-03-08
- Days to decision
- 211 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- Approval for new packaging and labeling site to CooperVision Manufacturing, Ltd, Southampton, United Kingdom.
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