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 | SILICONE AND PMMA INTRAOCULAR LENSES AND OCUCOAT |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | Bausch & Lomb, Inc. 50 Technology Irvine, CA 92618 |
PMA Number | P840039 |
Supplement Number | S053 |
Date Received | 03/18/2004 |
Decision Date | 06/14/2004 |
Product Code |
HQL |
Advisory Committee |
Ophthalmic |
Supplement Type | Real-Time Process |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE USE OF A 100% ETHYLENE OXIDE STERILIZATION METHOD IN PRODUCTS IN THEIR FINAL PACKAGED FORM. STERILIZATION WILL OCCUR AT COSMED, INC., LOCATED IN SOUTH PLAINFIELD NEW JERSEY. THE PRODUCTS AFFECTED BY THIS CHANGE ARE THE PMMA AND SILICONE LENSES AND OCUCOAT VISCOADHERENT MANUFACTURED AT BAUSCH & LOMB, INC., CLEARWATER, FLORIDA. |
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