BIOMEDICS 55 (OCUFILCON D) SOFT (HYDROPHILIC) EXTENDED-WEAR CONTACT LENSES
FDA premarket approval P890023/S023 · decided 2015-07-28
Approval details
- PMA number
- P890023
- Supplement
- S023
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BIOMEDICS 55 (OCUFILCON D) SOFT (HYDROPHILIC) EXTENDED-WEAR CONTACT LENSES
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- The Cooper Companies
- Date received
- 2015-07-02
- Decision date
- 2015-07-28
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- ADDITION OF A NEW AUTOCLAVE AT YOUR PUERTO RICO MANUFACTURING FACILITY.
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