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 |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | Bausch & Lomb, Inc. 50 Technology Drive Irvine, CA 92618 |
PMA Number | P060022 |
Supplement Number | S012 |
Date Received | 06/21/2011 |
Decision Date | 06/18/2012 |
Product Code |
HQL |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR MODIFICATIONS TO THE PRIMARY PACKAGING WHICH INCLUDES AN ALTERNATE PLASTIC VIAL AND INTRAOCULAR LENS (IOL) HOLDER. |
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