PMA P080011S066

Device: Natural Eyes Hydra Wear XW and Natural Eyes XW for Astigmatism
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S066
Product code: LPM
Decision date: 2018-04-10
Classification: Lenses, Soft Contact, Extended Wear
Generic name: Lenses, soft contact, extended wear
Approval order statement: Approval to add a new private label brand name, Natural Eyes Hydra Wear XW and Natural Eyes Hydra Wear for Astagmatism.

Current openFDA PMA Record#

Device: Natural Eyes Hydra Wear XW and Natural Eyes XW for Astigmatism
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S066
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2018-04-10
Decision code: APPR
Date received: 2017-12-19
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval to add a new private label brand name, Natural Eyes Hydra Wear XW and Natural Eyes Hydra Wear for Astagmatism.