- Device
- BIOMEDICS 55 (OCUFILCON D) UV BLOCKER IMT SOFT (HYDROPHILIC) CONTACT LENSES FOR EXTENDED WEAR
- Applicant
- The Cooper Companies
- PMA number
- P890023
- Supplement
- S008
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 1999-08-13
- Decision code
- OK30
- Date received
- 1999-07-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- The 30-Day Notice requested a UV blocker process change at Ocular Sciences' Santa Isabel facility.