VISTAKON (SENOFILCON A)
FDA premarket approval P040045/S036 · decided 2013-02-27
Approval details
- PMA number
- P040045
- Supplement
- S036
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VISTAKON (SENOFILCON A)
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Vistakon, Division of Johnson & Johnson Vision Car
- Date received
- 2013-01-28
- Decision date
- 2013-02-27
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- IMPLEMENTATION OF AN ALTERNATE INJECTION MOLDING MACHINE.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.