- Device
- HYDROCURVE (BUFILCON A CONTACT LENSES)
- Applicant
- Ciba Vision Corporation
- PMA number
- N17752
- Supplement
- S036
- Product code
- LPL
- Generic name
- Lenses, soft contact, daily wear
- Decision date
- 1995-09-22
- Decision code
- APPR
- Date received
- 1995-05-15
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR AN ALTERNATE MANUFACTURING PROCESS USING ULTRAVIOLET LIGHT INITIATOR IN THE MODIFIED CURE PROCESS FOR BUFILCON A (55% WATER) CONTACT LENSES AS REFERENCED ABOVE