ocufilcon D Soft (Hydrophilic) Extended Wear Contact Lenses
FDA premarket approval P890023/S038 · decided 2019-09-10
Approval details
- PMA number
- P890023
- Supplement
- S038
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ocufilcon D Soft (Hydrophilic) Extended Wear Contact Lenses
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- The Cooper Companies
- Date received
- 2019-08-13
- Decision date
- 2019-09-10
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- Introduction of a new flow cytometry analyzer to be used in replacement of the current cytometry analyzer at the CooperVision Caribbean Corporation facility in Juana Diaz, Puerto Rico.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.