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 | ANTERIOR CHAMBER POLYMETHYLMETHACRYLATE (PMMA) INTRAOCULAR LENSES (IOLS) |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | Bausch & Lomb, Inc. 50 Technology Drive Irvine, CA 92618 |
PMA Number | P880090 |
Supplement Number | S024 |
Date Received | 04/04/2008 |
Decision Date | 06/09/2008 |
Product Code |
HQL |
Advisory Committee |
Ophthalmic |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO CHANGE THE LENS CARRIER TO THE ROTARY CAP CARRIER, PN/ 14937-62, FOR THE ANTERIOR CHAMBER IOLS. |
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