OCUFILCON D EXTENDED-WEAR LENSES
FDA premarket approval P890023/S021 · decided 2015-01-09
Approval details
- PMA number
- P890023
- Supplement
- S021
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- OCUFILCON D EXTENDED-WEAR LENSES
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- The Cooper Companies
- Date received
- 2013-11-13
- Decision date
- 2015-01-09
- Days to decision
- 422 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- APPROVAL FOR A NEW TEST METHOD FOR BIOBURDEN ENUMERATION.
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