VISTAKON (SENOFILCON A) BRAND CONTACT LENSES
FDA premarket approval P040045/S050 · decided 2015-05-01
Approval details
- PMA number
- P040045
- Supplement
- S050
- Supplement type
- 30-Day Notice
- Trade name
- VISTAKON (SENOFILCON A) BRAND CONTACT LENSES
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Vistakon, Division of Johnson & Johnson Vision Car
- Date received
- 2015-04-03
- Decision date
- 2015-05-01
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- IMPLEMENTATION OF A SECOND SUPPLIER SOURCE FOR THE PRIMARY PACKAGE BLISTER BOWL.
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