- Device
- Lotrafilcon B soft Contact Lenses for daily and extended wear
- Applicant
- Alcon Laboratories, Inc.
- PMA number
- P010019
- Supplement
- S077
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2020-12-14
- Decision code
- OK30
- Date received
- 2020-11-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- expansion of production site manufacturing operations for addition of AIR OPTIX plus HydraGlyde for ASTIGMATISM (lotrafilcon B) soft contact lenses