PMA P860023
- Device
- Bausch & Lomb(r) Renu(r) Multi-purpose Solution
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P860023
- Supplement
- S012
- Decision date
- 1997-07-03
Current openFDA PMA Record
- Device
- BAUSCH & LOMB(R) RENU(R) MULTI-PURPOSE SOLUTION
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P860023
- Supplement
- S012
- Product code
- LPN
- Generic name
- Accessories, soft lens products
- Decision date
- 1997-07-03
- Decision code
- APPR
- Date received
- 1996-11-13
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A CHANGE IN THE FORMULATION AND CORRESPONDING MODIFICATIONS TO THE LABELING. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BAUSCH & LOMB RENU MULTIPLUS(TM) MULTI-PURPOSE SOLUTION AND IS INDICATED FOR USE IN THE DAILY CLEANING, PROMOTION OF DAILY PROTEIN REMOVAL, RINSING, CHEMICAL (NOT HEAT) DISINFECTION AND STORAGE OF SOFT (HYDROPHILIC) CONTACT LENSES AS RECOMMENDED BY THE EYE CARE PRACTITIONER.