VISTAKON (ETAFILCON A) CONTACT LENS
FDA premarket approval N18033/S044 · decided 2010-08-09
Approval details
- PMA number
- N18033
- Supplement
- S044
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VISTAKON (ETAFILCON A) CONTACT LENS
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Vistakon, Johnson & Johnson Vision Products, Inc.
- Date received
- 2010-03-08
- Decision date
- 2010-08-09
- Days to decision
- 154 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- APPROVAL FOR A CHANGE IN A TEST METHOD TO A FINISHED DEVICE CONTACT LENS MATERIAL.
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