SATURN II(TM) (SYNERGICON A) CONTACT LENS
FDA premarket approval P840004/S007 · decided 1993-10-14
Approval details
- PMA number
- P840004
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SATURN II(TM) (SYNERGICON A) CONTACT LENS
- Generic name
- Lens, contact (polymethylmethacrylate)
- Applicant
- Wesley Jessen Corp.
- Date received
- 1992-11-06
- Decision date
- 1993-10-14
- Days to decision
- 342 days
- Decision code
- APPR
- Product code
- HPX
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Des Plaines, IL
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