PMA P080011S058

Device: iWear oxygen and iWear oxygen astigmatism
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S058
Product code: LPM
Decision date: 2017-05-05
Classification: Lenses, Soft Contact, Extended Wear
Generic name: Lenses, soft contact, extended wear
Approval order statement: Approval for labeling change to add new private label brand name, iWear oxygen and iWear oxygen astigmatism. The name iWear oxygen is intended for the spherical lenses and iWear oxygen astigmatism for the toric lenses.

Current openFDA PMA Record#

Device: iWear oxygen and iWear oxygen astigmatism
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S058
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2017-05-05
Decision code: APPR
Date received: 2017-03-27
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for labeling change to add new private label brand name, iWear oxygen and iWear oxygen astigmatism. The name iWear oxygen is intended for the spherical lenses and iWear oxygen astigmatism for the toric lenses.