VISTAKON (etafilcon A) ACUVUE 2 Brand Contact Lenses
FDA premarket approval N18033/S098 · decided 2018-05-24
Approval details
- PMA number
- N18033
- Supplement
- S098
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VISTAKON (etafilcon A) ACUVUE 2 Brand Contact Lenses
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Vistakon, Johnson & Johnson Vision Products, Inc.
- Date received
- 2018-04-30
- Decision date
- 2018-05-24
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- Conversion of an existing production line to produce VISTAKON® (etafilcon A) ACUVUE® 2 Brand Contact Lenses.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.