PMA P820031S014

Device: SENSITIVE EYES(TM) SALINE & CLEANING SOLUTION
Applicant: Bausch & Lomb, Inc.
PMA number: P820031
Supplement: S014
Product code: LPN
Decision date: 1997-03-10
Generic name: Accessories, soft lens products
Approval order statement: APPROVAL FOR REDUCING THE FILL VOLUME FOR RENU(R) LENS REWETTING DROPS FROM THE CURRENTLY APPROVED 5 ML TO 3 ML IN THE SAME 7.5 ML BOTTLE.

Current openFDA PMA Record

Device: SENSITIVE EYES(TM) SALINE & CLEANING SOLUTION
Applicant: Bausch & Lomb, Inc.
PMA number: P820031
Supplement: S014
Product code: LPN
Generic name: Accessories, soft lens products
Decision date: 1997-03-10
Decision code: APPR
Date received: 1996-10-10
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR REDUCING THE FILL VOLUME FOR RENU(R) LENS REWETTING DROPS FROM THE CURRENTLY APPROVED 5 ML TO 3 ML IN THE SAME 7.5 ML BOTTLE.