- Device
- PHEMFILCON A SOFT (HYCROPHILIC) CONTACT LENS
- Applicant
- Alcon Laboratories, Inc.
- PMA number
- P830037
- Supplement
- S044
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2001-09-14
- Decision code
- APPR
- Date received
- 2001-03-05
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MATERIAL CHANGE TO INCORPORATE THE USE OF A DIFFERENT ADHESION PROMOTER TO BE USED IN THE PIGMENT APPLICATION PROCESS.