VISTAKON (etafilcon A) Brand Contact Lenses.
FDA premarket approval N18033/S101 · decided 2019-05-31
Approval details
- PMA number
- N18033
- Supplement
- S101
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VISTAKON (etafilcon A) Brand Contact Lenses.
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Vistakon, Johnson & Johnson Vision Products, Inc.
- Date received
- 2018-12-21
- Decision date
- 2019-05-31
- Days to decision
- 161 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- Approval to use alternate photoinitiator.
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