BIOFINITY (CONFILCON A) SOFT CONTACT LENSES
FDA premarket approval P080011/S018 · decided 2012-11-01
Approval details
- PMA number
- P080011
- Supplement
- S018
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BIOFINITY (CONFILCON A) SOFT CONTACT LENSES
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2012-09-17
- Decision date
- 2012-11-01
- Days to decision
- 45 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT COOPERVISION CARIBBEAN CORPORATION IN JUANA DIAZ, PUERTO RICO.
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