- Device
- JSZ ORTHOKERATOLOGY (OPRIFOCON A) CONTACT LENSES FOR OVERNIGHT WEAR
- Applicant
- Euclid Vision Corporation
- PMA number
- P040029
- Supplement
- S002
- Product code
- NUU
- Generic name
- Lens, contact, orthokeratology, overnight
- Decision date
- 2016-01-29
- Decision code
- APPR
- Date received
- 2015-08-03
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR UPDATED LABELING REFLECTING LONG-TERM DATA FROM THE POST-APPROVAL STUDY.