EQUATE ASPHERE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENSES, EQUATE TORIC (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LE
FDA premarket approval P890023/S022 · decided 2014-11-21
Approval details
- PMA number
- P890023
- Supplement
- S022
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- EQUATE ASPHERE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENSES, EQUATE TORIC (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LE
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- The Cooper Companies
- Date received
- 2014-09-08
- Decision date
- 2014-11-21
- Days to decision
- 74 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- APPROVAL FOR THE ADDITION OF THE NEW PRIVATE LABEL BRAND NAME EQUATE ASPHERE AND EQUATE TORIC TO THE DEVICE LABELING.
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