PMA P080011S191

Device: Sofmed® breathables™ XW NEXT
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S191
Product code: LPM
Decision date: 2025-12-05
Classification: Ophthalmic
Generic name: Lenses, soft contact, extended wear
Approval order statement: re-branding of the Biofinity® (comfilcon A) Soft Contact Lenses for Extended Wear to the new private label trade name “Sofmed® breathables™ XW NEXT.

Current openFDA PMA Record#

Device: Sofmed® breathables™ XW NEXT
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S191
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2025-12-05
Decision code: APPR
Date received: 2025-07-18
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: re-branding of the Biofinity® (comfilcon A) Soft Contact Lenses for Extended Wear to the new private label trade name “Sofmed® breathables™ XW NEXT.