PMA P860023S010

Device: BAUSCH & LOMB(R) RENU(R) MULTI-PURPOSE SOLUTION
Applicant: Bausch & Lomb, Inc.
PMA number: P860023
Supplement: S010
Product code: LPN
Decision date: 1996-09-27
Generic name: Accessories, soft lens products
Approval order statement: APPROVAL FOR MODIFYING THE CURRENT EYE CARE PRACTITIONER TRIAL LENS DISINFECTION AND STORAGE INSTRUCTIONS TO EXTEND THE MAXIMUM RECOMMENDED STORAGE TIME FROM THE CURRENTLY APPROVED 7 DAYS TO 30 DAYS IN BAUSCH & LOMB RE NU MULTI-PURPOSE SOLUTION. ALL OTHER ASPECTS OF THE LABELING REMAIN UNCHANGED FROM THOSE PREVIOUSLY APPROVED

Current openFDA PMA Record

Device: BAUSCH & LOMB(R) RENU(R) MULTI-PURPOSE SOLUTION
Applicant: Bausch & Lomb, Inc.
PMA number: P860023
Supplement: S010
Product code: LPN
Generic name: Accessories, soft lens products
Decision date: 1996-09-27
Decision code: APPR
Date received: 1996-04-03
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR MODIFYING THE CURRENT EYE CARE PRACTITIONER TRIAL LENS DISINFECTION AND STORAGE INSTRUCTIONS TO EXTEND THE MAXIMUM RECOMMENDED STORAGE TIME FROM THE CURRENTLY APPROVED 7 DAYS TO 30 DAYS IN BAUSCH & LOMB RE NU MULTI-PURPOSE SOLUTION. ALL OTHER ASPECTS OF THE LABELING REMAIN UNCHANGED FROM THOSE PREVIOUSLY APPROVED