PMA P820001S021
- Device
- Opti-zyme Enzymatic Cleaner
- Applicant
- ALCON LABORATORIES
- PMA number
- P820001
- Supplement
- S021
- Decision date
- 1997-05-15
Current openFDA PMA Record
- Device
- OPTI-ZYME ENZYMATIC CLEANER
- Applicant
- Alcon Laboratories
- PMA number
- P820001
- Supplement
- S021
- Product code
- LPN
- Generic name
- Accessories, soft lens products
- Decision date
- 1997-05-15
- Decision code
- APPR
- Date received
- 1996-12-18
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR (1) USE OF OPTI-SOAK(R) CONDITIONING SOLUTION AS AN ALTERNATE DILUENT FOR OPTI-FREE(R) SUPRACLENS(TM) DAILY PROTEIN REMOVER, (2) TO EXPAND THE INDICATIONS FOR USE OF OPTI-FREE(R) SUPRACLENS(TM) TO ALLOW FOR USE WITH RIGID GAS PERMEABLE (RGP) CONTACT LENSES, AND (3) FOR USE OF OPTI-CLEAN(R) II DAILY CLEANER AS AN ALTERNATE DAILY CLEANER IN THE OPTI-SOAK(R) LENS CARE REGIMEN.