Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | AcrySof Single Piece Intraocular Lenses |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | ALCON LABORATORIES, INC. 6201 SOUTH FREEWAY DR. FORT WORTH, TX 76134 |
PMA Number | P930014 |
Supplement Number | S106 |
Date Received | 11/13/2017 |
Decision Date | 11/30/2017 |
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 Implementation of a new test method for determining the % Purity of an AcrySof Intraocular Lens raw material. |
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