|
Device | ACRYSOF RESTOR POSTERIOR CHAMBER INTRAOCULAR LENS |
Generic Name | Lens, multifocal intraocular |
Regulation Number | 886.3600 |
Applicant | Alcon Research, Ltd. 6201 South Freeway Fort Worth, TX 76134-2099 |
PMA Number | P040020 |
Supplement Number | S059 |
Date Received | 12/09/2015 |
Decision Date | 01/06/2016 |
Product Code |
MFK |
Advisory Committee |
Ophthalmic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement REQUESTED PARAMETRIC RELEASE FOR THE ALCON HUNTINGTON AODC NORTH (AODC-N) ETHYLENE OXIDE STERILIZATION PROCESS. |