MOLDED ETAFILCON A SOFT CONTACT LENSES
FDA premarket approval N18033/S032 · decided 1999-03-16
Approval details
- PMA number
- N18033
- Supplement
- S032
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MOLDED ETAFILCON A SOFT CONTACT LENSES
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Vistakon, Johnson & Johnson Vision Products, Inc.
- Date received
- 1999-03-01
- Decision date
- 1999-03-16
- Days to decision
- 15 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- Approval for an alternate shelf-life protocol.
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