- Device
- LOTRAFILCON B SOFT CONTACT LENSES O2OPTIX, AIR OPTIX AQUA, AIR OPTIX FOR ASTIGMATISM, AIR OPTIX AQUA MULTIFOCAL.
- Applicant
- Alcon Laboratories, Inc.
- PMA number
- P010019
- Supplement
- S042
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2015-12-03
- Decision code
- OK30
- Date received
- 2015-11-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- TO INTRODUCE AN ALTERNATE SOURCE/MANUFACTURER OF POLYPROPYLENE MOLDED BLISTER SHELLS FOR PACKAGING.