|
Device | PMMA SINGLE-PIECE ANTERIOR CHAMBER INTRAOCULAR LENSES |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | ALCON LABORATORIES 6201 S FREEWAY FT WORTH, TX 76134 |
PMA Number | P880087 |
Supplement Number | S011 |
Date Received | 10/18/2004 |
Decision Date | 03/04/2005 |
Product Code |
HQL |
Advisory Committee |
Ophthalmic |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE USE OF AN ADDITIONAL SUPPLIER OF POLYMETHYLMETHACRYLATE (PMMA) FOR THE PMMA IOLS. |