PMA P080011S184

Device: up&up Monthly Performance +
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S184
Product code: LPM
Decision date: 2025-08-20
Classification: Ophthalmic
Generic name: Lenses, soft contact, extended wear
Approval order statement: approval for trade name change for CooperVision comfilcon A soft (hydrophilic) contact lenses for extended wear to add up&up Monthly Performance + (intended for the aspherical lens design)

Current openFDA PMA Record#

Device: up&up Monthly Performance +
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S184
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2025-08-20
Decision code: APPR
Date received: 2025-02-25
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: approval for trade name change for CooperVision comfilcon A soft (hydrophilic) contact lenses for extended wear to add up&up Monthly Performance + (intended for the aspherical lens design)