ocufilcon D Sift (Hydrophilie) Contact Lenses
FDA premarket approval P890023/S028 · decided 2017-12-19
Approval details
- PMA number
- P890023
- Supplement
- S028
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ocufilcon D Sift (Hydrophilie) Contact Lenses
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- The Cooper Companies
- Date received
- 2017-08-04
- Decision date
- 2017-12-19
- Days to decision
- 137 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- Approval for a change in the test specifications of the saline solutions that are manufactured at the CooperVision Caribbean Corporation manufacturing facility in Juana Diaz, Puerto Rico and used in the packaging of ocufilcon D Soft (Hydrophilic) Contact Lenses in blister containers.
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