VISTAKON (etafilcon A) Brand Contact Lenses
FDA premarket approval N18033/S099 · decided 2018-07-10
Approval details
- PMA number
- N18033
- Supplement
- S099
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VISTAKON (etafilcon A) Brand Contact Lenses
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Vistakon, Johnson & Johnson Vision Products, Inc.
- Date received
- 2018-06-18
- Decision date
- 2018-07-10
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- Modification of the heat seal mechanism used to seal the foil lidstock onto the primary package during the manufacturing process of VISTAKON® (etafilcon A) Brand Contact Lenses.
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