- Device
- CLARIS(TM) REWETTING DROPS
- Applicant
- Advanced Medical Optics, Inc.
- PMA number
- P900047
- Supplement
- S005
- Product code
- LPN
- Generic name
- Accessories, soft lens products
- Decision date
- 1996-06-20
- Decision code
- APPR
- Date received
- 1996-03-01
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL TO 1)DUPLICATE WET-N-SOAK REWETTING DROPS UNDER THE TRADE NAME CLARIS REWETTING DROPS TO BE USED WITH CLARIS CLEANING AND SOAKING SOLUTION (ALLERGAN'S TRADE NAME FOR DESTAT 4 CLEANING, DISINFECTING, STORAGE SOLUTION (P870023)) AND 2)ADD THE FOLLOWING TO THE DIRECTIONS SECTION FOR CLARIS REWETTING DROPS: BEFORE WEARING LENSES: PLACE 1 OR 2 DROPS OF CLARIS REWETTING DROPS ON EACH SIDE OF EACH LENS BEFORE APPLICATION