VISTAKON(etafilcon A) brand contact lenses
FDA premarket approval N18033/S082 · decided 2016-08-10
Approval details
- PMA number
- N18033
- Supplement
- S082
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- VISTAKON(etafilcon A) brand contact lenses
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Vistakon, Johnson & Johnson Vision Products, Inc.
- Date received
- 2016-07-13
- Decision date
- 2016-08-10
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- Approval for labeling modifications to the device.
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