VISTAKON (ETAFILCONA) CONTACT LENSES, CLEAR & VISIBILITY TINRED WITH UV BLOCKER
FDA premarket approval N18033/S053 · decided 2011-02-14
Approval details
- PMA number
- N18033
- Supplement
- S053
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VISTAKON (ETAFILCONA) CONTACT LENSES, CLEAR & VISIBILITY TINRED WITH UV BLOCKER
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Vistakon, Johnson & Johnson Vision Products, Inc.
- Date received
- 2011-01-18
- Decision date
- 2011-02-14
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- IMPLEMENTATION OF AN ALTERNATE TEST METHOD FOR DETERMINING THE PURITY IN THE RAW MATERIAL, METHACRYLIC ACID, USED IN THE VISTAKON® (ETAFILCON A) SOFT 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.