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Device | BIOCURVE SOFT EW (METHAFILCON A) HYDROPHILIC CONTACT LENSES |
Generic Name | Lenses, soft contact, extended wear |
Regulation Number | 886.5925 |
Applicant | WAVETOUCH TECHNOLOGIES, LLC 15970 BERNARDO CENTER DR. SAN DIEGO, CA 92127 |
PMA Number | P860040 |
Supplement Number | S014 |
Date Received | 04/01/1997 |
Decision Date | 11/04/1997 |
Product Code |
LPM |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order 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. |