VISTAKON (ETAFILICON A) HYDROPHILIC CONTACT LENS
FDA premarket approval N18033/S025 · decided 1991-01-24
Approval details
- PMA number
- N18033
- Supplement
- S025
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Other
- Trade name
- VISTAKON (ETAFILICON A) HYDROPHILIC CONTACT LENS
- Generic name
- Lenses, soft contact, daily wear
- Applicant
- Vistakon, Johnson & Johnson Vision Products, Inc.
- Date received
- 1990-09-21
- Decision date
- 1991-01-24
- Days to decision
- 125 days
- Decision code
- APPR
- Product code
- LPL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Jacksonville, FL
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.