BIOFINITY CONTACT LENSES
FDA premarket approval P080011/S004 · decided 2011-03-23
Approval details
- PMA number
- P080011
- Supplement
- S004
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BIOFINITY CONTACT LENSES
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2011-02-24
- Decision date
- 2011-03-23
- Days to decision
- 27 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- ALTERNATE LABELING AND PACKING SITE LOCATED AT COOPERVISION INC. IN WEST HENRIETTA, NEW YORK.
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