VISTAKON (ETAFILCON A) BRAND CONTACT LENSES
FDA premarket approval N18033/S064 · decided 2012-03-26
Approval details
- PMA number
- N18033
- Supplement
- S064
- Supplement type
- 30-Day Notice
- Trade name
- VISTAKON (ETAFILCON A) BRAND CONTACT LENSES
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Vistakon, Johnson & Johnson Vision Products, Inc.
- Date received
- 2012-02-28
- Decision date
- 2012-03-26
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- USE AN ALTERNATE PROCESS FOR REMOVING THE BACK CURVE PLASTIC MOLD FROM THE CURED LENS DURING MANUFACTURING.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.