BIOCURVE SOFT EW (METHAFILCON A) HYDROPHILIC CONTACT LENSES
FDA premarket approval P860040/S015 · decided 1999-03-04
Approval details
- PMA number
- P860040
- Supplement
- S015
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BIOCURVE SOFT EW (METHAFILCON A) HYDROPHILIC CONTACT LENSES
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Wavetouch Technologies, LLC
- Date received
- 1998-05-19
- Decision date
- 1999-03-04
- Days to decision
- 289 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- Approval for a toric configuration of the BIOCURVE SOFT FW (methafilcon A) CONTACT LENS (clear and handling tint). The device, as modified, will be marketed under the trade name BIOCURVE SOFT TORIC FW (methafilcon A) CONTACT LENS and is indicated for daily wear or extended wear by not-aphakic persons with non-diseased eyes. The lenses are for the correct of refractive ametropia (myopia, hyperopia, and astigmatism). The spherical lens may be worn by persons with up to 1.50 diopters of astigmatism
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