BIOFINITY (COMFILCON) SOFT CONTACT LENS
FDA premarket approval P080011/S005 · decided 2011-12-20
Approval details
- PMA number
- P080011
- Supplement
- S005
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BIOFINITY (COMFILCON) SOFT CONTACT LENS
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2011-08-11
- Decision date
- 2011-12-20
- Days to decision
- 131 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- APPROVAL TO ADD THE PRIVATE LABEL NAME AQUATECH PLUS PREMIUM TO THE LIST OF APPROVED NAMES FOR THE DEVICE.
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