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 | AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS, AO60, M160 |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | Bausch & Lomb, Inc. 50 Technology Drive Irvine, CA 92618 |
PMA Number | P060022 |
Supplement Number | S014 |
Date Received | 08/20/2012 |
Decision Date | 10/04/2012 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement NEW SUPPLIER FOR THE 2-HYDROXYL ETHYL METHACRYLATE (HEMA) MONOMER USED IN THE MANUFACTURE OF AKREOS IOLS. |
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