|
Device | MENICON SF-P (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS |
Generic Name | Lens, contact (other material) - daily |
Applicant | MENICON CO. LTD. 269A BALLARDVALE ST. WILMINGTON, MA 01887 |
PMA Number | P880098 |
Supplement Number | S012 |
Date Received | 11/19/2002 |
Decision Date | 12/10/2002 |
Withdrawal Date
|
05/05/2008 |
Product Codes |
HQD MWL |
Advisory Committee |
Ophthalmic |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR ALCON UNIQUE-PH MULTI-PURPOSE SOLUTION AS AN ALTERNATE WET SHIPPING SOLUTION FOR THE MENICON SF-P RIGID GAS PERMEABLE CONTACT LENS, LABELING CHANGES TO REFLECT THE USE OF ALCON UNIQUE-PH AS A PACKAGING SOLUTION AND TO UPDATE THE LABELING IN ACCORDANCE WITH RECENTLY APPROVED MENICON RIGID GAS PERMEABLE CONTACT LENS LABELING. |