|
Device | Multi-Piece Posterior Chamber IOL |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | ALCON LABORATORIES 6201 S FREEWAY FT WORTH, TX 76134 |
PMA Number | P810032 |
Supplement Number | S065 |
Date Received | 07/29/2016 |
Decision Date | 03/03/2017 |
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 to move the testing for bacterial endotoxins and microvacuoles from post-sterilization to pre-sterilization after device packaging. |