BIOCURVE SOFT EW (METHAFILCON A) HYDROPHILIC CONTACT LENSES
FDA premarket approval P860040/S014 · decided 1997-11-04
Approval details
- PMA number
- P860040
- Supplement
- S014
- 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
- 1997-04-01
- Decision date
- 1997-11-04
- Days to decision
- 217 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- Approval for adding a visibility tint to the contact lens and revised labeling for the spherical lens to reflect the addition ofthe visibility tint. There are no changes in the previously approved indications for use.
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