PMA P850079S028

Device: HYDRASOFT, HYDRASOFT TORIC, HYDRASOFT XW AND HYDRASOFT TORIC XW (METHALICON B) SOFT (HYDROPHILIC) CONTACT LENSES
Applicant: CooperVision, Inc.
PMA number: P850079
Supplement: S028
Product code: LPL
Decision date: 1996-08-01
Classification: Lenses, Soft Contact, Daily Wear
Generic name: Lenses, soft contact, daily wear
Approval order statement: APPROVAL FOR REFORMATTING THE PACKAGE INSERT, PROFESSIONAL FITTING AND INFORMATION GUIDE, AND PATIENT INSTRUCTIONS. THE MODIFIED LABELING DOES NOT RESULT IN CHANGES IN THE INDICATIONS FOR USE FOR THE DEVICES

Current openFDA PMA Record#

Device: HYDRASOFT, HYDRASOFT TORIC, HYDRASOFT XW AND HYDRASOFT TORIC XW (METHALICON B) SOFT (HYDROPHILIC) CONTACT LENSES
Applicant: CooperVision, Inc.
PMA number: P850079
Supplement: S028
Product code: LPL
Generic name: Lenses, soft contact, daily wear
Decision date: 1996-08-01
Decision code: APPR
Date received: 1996-07-12
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR REFORMATTING THE PACKAGE INSERT, PROFESSIONAL FITTING AND INFORMATION GUIDE, AND PATIENT INSTRUCTIONS. THE MODIFIED LABELING DOES NOT RESULT IN CHANGES IN THE INDICATIONS FOR USE FOR THE DEVICES