PMA P990018S006

Device: ACUVUE® Abiliti™ Overnight and ACUVUE® Abiliti™ Overnight Therapeutic Lenses for Myopia Management
Applicant: Menicon Co, Ltd.
PMA number: P990018
Supplement: S006
Product code: NUU
Decision date: 2021-05-06
Generic name: Lens, contact, orthokeratology, overnight
Approval order statement: Approval for addition of the following private label trade names for the Menicon Z Night (tisilfocon A) Contact Lenses for Overnight Wear: ACUVUE® Abiliti Overnight and ACUVUE® Abiliti Overnight Therapeutic Lenses for Myopia Management.

Current openFDA PMA Record#

Device: ACUVUE® Abiliti™ Overnight and ACUVUE® Abiliti™ Overnight Therapeutic Lenses for Myopia Management
Applicant: Menicon Co, Ltd.
PMA number: P990018
Supplement: S006
Product code: NUU
Generic name: Lens, contact, orthokeratology, overnight
Decision date: 2021-05-06
Decision code: APPR
Date received: 2021-01-21
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for addition of the following private label trade names for the Menicon Z Night (tisilfocon A) Contact Lenses for Overnight Wear: ACUVUE® Abiliti Overnight and ACUVUE® Abiliti Overnight Therapeutic Lenses for Myopia Management.