POLYCON (SILAFOCON A) CONTACT LENSES
FDA premarket approval N18120/S027 · decided 1991-06-24
Approval details
- PMA number
- N18120
- Supplement
- S027
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- POLYCON (SILAFOCON A) CONTACT LENSES
- Generic name
- Lens, contact (polymethylmethacrylate)
- Applicant
- Wesley Jessen Corp.
- Date received
- 1990-12-28
- Decision date
- 1991-06-24
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- HPX
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Des Plaines, IL
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