|
Device | BAUSCH & LOMB(R) RENU(R) MULTI-PURPOSE SOLUTION |
Generic Name | Accessories, soft lens products |
Regulation Number | 886.5928 |
Applicant | Bausch & Lomb, Inc. 14853 DEVEAU PLACE MINNETONKA, MN 55345 |
PMA Number | P860023 |
Supplement Number | S010 |
Date Received | 04/03/1996 |
Decision Date | 09/27/1996 |
Product Code |
LPN |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
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 |