PMA P050031S001

Device: PARAGON CRT LENS
Applicant: CooperVision, Inc.
PMA number: P050031
Supplement: S001
Product code: MWL
Decision date: 2014-07-28
Classification: Lens, Contact (rigid Gas Permeable), Extended Wear
Generic name: Lens, contact (rigid gas permeable), extended wear
Approval order statement: APPROVAL FOR A LABELING UPDATE TO THE PACKAGE INSERT AND PATIENT INFORMATION BOOKLET TO INCLUDE THE RESULTS FROM A SECTION 522 POSTMARKET SURVEILLANCE STUDY (PAS).

Current openFDA PMA Record#

Device: PARAGON CRT LENS
Applicant: CooperVision, Inc.
PMA number: P050031
Supplement: S001
Product code: MWL
Generic name: Lens, contact (rigid gas permeable), extended wear
Decision date: 2014-07-28
Decision code: APPR
Date received: 2010-10-25
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR A LABELING UPDATE TO THE PACKAGE INSERT AND PATIENT INFORMATION BOOKLET TO INCLUDE THE RESULTS FROM A SECTION 522 POSTMARKET SURVEILLANCE STUDY (PAS).