Biomedics 55 (ocufilcon D) Soft (Hydrophilic) Contact Lenses for Extended Wear
FDA premarket approval P890023/S044 · decided 2020-09-16
Approval details
- PMA number
- P890023
- Supplement
- S044
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Biomedics 55 (ocufilcon D) Soft (Hydrophilic) Contact Lenses for Extended Wear
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- The Cooper Companies
- Date received
- 2020-08-20
- Decision date
- 2020-09-16
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- Implementation of a new sterilizer installed at the CooperVision Manufacturing facility in Juana Diaz, Puerto Rico.
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