OCUFILCON D SOFT (HYDROPHILIC) CONTACT LENSES
FDA premarket approval P890023/S024 · decided 2016-01-11
Approval details
- PMA number
- P890023
- Supplement
- S024
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- OCUFILCON D SOFT (HYDROPHILIC) CONTACT LENSES
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- The Cooper Companies
- Date received
- 2015-12-22
- Decision date
- 2016-01-11
- Days to decision
- 20 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- RELOCATION OF THE BIOMEDICS TORIC WET CELL, INSTALLATION OF A NEW TC20I UNIT IN THE BIOMEDICS TORIC QA STATION AND A SOFTWARE UPDATE FOR QA FINAL INSPECTION PRIOR TO MEASUREMENT OF TORIC LENSES.
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