|
Device | PMMA SINGLE-PIECE POSTERIOR CHAMBER INTRAOCULAR LENS |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | ALCON LABORATORIES 6201 S FREEWAY FT WORTH, TX 76134 |
PMA Number | P840060 |
Supplement Number | S041 |
Date Received | 12/09/2015 |
Decision Date | 01/06/2016 |
Product Code |
HQL |
Advisory Committee |
Ophthalmic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement REQUESTED PARAMETRIC RELEASE FOR THE ALCON HUNTINGTON AODC NORTH (AODC-N) ETHYLENE OXIDE STERILIZATION PROCESS. |