PMA P860040S014

Device: BIOCURVE SOFT EW (METHAFILCON A) HYDROPHILIC CONTACT LENSES
Applicant: Wavetouch Technologies, LLC
PMA number: P860040
Supplement: S014
Product code: LPM
Decision date: 1997-11-04
Classification: Lenses, Soft Contact, Extended Wear
Generic name: Lenses, soft contact, extended wear
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.

Current openFDA PMA Record#

Device: BIOCURVE SOFT EW (METHAFILCON A) HYDROPHILIC CONTACT LENSES
Applicant: Wavetouch Technologies, LLC
PMA number: P860040
Supplement: S014
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 1997-11-04
Decision code: APPR
Date received: 1997-04-01
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
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.