VISTAKON (ETAFILCON A) CONTACT LENSES
FDA premarket approval N18033/S048 · decided 2011-03-10
Approval details
- PMA number
- N18033
- Supplement
- S048
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VISTAKON (ETAFILCON A) CONTACT LENSES
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Vistakon, Johnson & Johnson Vision Products, Inc.
- Date received
- 2010-09-29
- Decision date
- 2011-03-10
- Days to decision
- 162 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- APPROVAL TO IMPLEMENT AN ALTERNATE METHOD FOR RE-SAMPLING 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.