PMA P990018S004
- Device
- MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS
- Applicant
- Menicon Co, Ltd.
- PMA number
- P990018
- Supplement
- S004
- Product code
- MWL
- Decision date
- 2010-02-25
- Classification
- Lens, Contact (rigid Gas Permeable), Extended Wear
- Generic name
- Lens, contact (rigid gas permeable), extended wear
- Approval order statement
- APPROVAL FOR MODIFIED LABELING TO INCLUDE INFORMATION REGARDING THE POST-APPROVAL STUDY.
Current openFDA PMA Record#
- Device
- MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS
- Applicant
- Menicon Co, Ltd.
- PMA number
- P990018
- Supplement
- S004
- Product code
- MWL
- Generic name
- Lens, contact (rigid gas permeable), extended wear
- Decision date
- 2010-02-25
- Decision code
- APPR
- Date received
- 2009-04-01
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- APPROVAL FOR MODIFIED LABELING TO INCLUDE INFORMATION REGARDING THE POST-APPROVAL STUDY.