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 ADVANCED OPTICS ASPHERIC LENS AND AKROES AO MICRO INCISION LENS |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | Bausch & Lomb, Inc. 50 Technology Drive Irvine, CA 92618 |
PMA Number | P060022 |
Supplement Number | S006 |
Date Received | 01/29/2010 |
Decision Date | 04/01/2010 |
Product Code |
HQL |
Advisory Committee |
Ophthalmic |
Supplement Type | Real-Time Process |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR DESIGN MODIFICATIONS TO MODEL MI60L AND USE OF MEDICEL VISCOJECT 2.2 LP60430 INSERTER WITH MODEL AO60 AND IS INDICATED FOR THE REPLACEMENT OF THE HUMAN CRYSTALLINE LENS IN THE VISUAL CORRECTION OF APHAKIA. |
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