PMA P820001S020
- Device
- Opti-free(r) Supraclens(tm) Daily Protein Remover
- Applicant
- ALCON LABORATORIES
- PMA number
- P820001
- Supplement
- S020
- Decision date
- 1997-02-10
Current openFDA PMA Record
- Device
- OPTI-FREE(R) SUPRACLENS(TM) DAILY PROTEIN REMOVER
- Applicant
- Alcon Laboratories
- PMA number
- P820001
- Supplement
- S020
- Product code
- LPN
- Generic name
- Accessories, soft lens products
- Decision date
- 1997-02-10
- Decision code
- APPR
- Date received
- 1996-08-20
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL TO REDUCE THE MINIMUM GAMMA RADIATION STERILIZATION DOESE SPECIFICATION FROM 25.0 KGY TO 16.2 KGY FOR THE MAJORITY OF PRIMARY PACKAGING COMPONENTS (BOTTLES, PLUGS AND CLOSURES) , AND FROM 25.0 KGY TO 18.0 KGY FOR THE 8 OZ. HIGH DENSITY POLYETHYLENE (HDPE)BOTTLES AND THE 15 OZ. LOW DENSITY POLYETHYLENE LDPE) BOTTLES.