HYDROGENICS 60 (OCUFILCON F) UV IMT SOFT (HYDROPHILIC) CONTACT LENS FOR EXTENDED WEAR
FDA premarket approval P890023/S014 · decided 2004-01-14
Approval details
- PMA number
- P890023
- Supplement
- S014
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Express GMP Supplement
- Trade name
- HYDROGENICS 60 (OCUFILCON F) UV IMT SOFT (HYDROPHILIC) CONTACT LENS FOR EXTENDED WEAR
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- The Cooper Companies
- Date received
- 2003-12-22
- Decision date
- 2004-01-14
- Days to decision
- 23 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- APPROVAL FOR MANUFACTURING SITES LOCATED AT OCULAR SCIENCES PUERTO RICO IN JUANA DIAZ, PUERTO RICO AND SANTA ISABEL, PUERTO RICO.
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