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 | AMVISC & AMVISC PLUS |
Generic Name | AID, SURGICAL, VISCOELASTIC |
Regulation Number | 886.4275 |
Applicant | Bausch & Lomb, Inc. 50 Technology Drive Irvine, CA 92618 |
PMA Number | P810025 |
Supplement Number | S028 |
Date Received | 06/21/2010 |
Decision Date | 05/15/2012 |
Product Code |
LZP |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR AN ALTERNATE RAW MATERIAL SOURCE (LIFECORES FERMENTATION-BASED SODIUM HYALURONATE) AND ALTERNATE MANUFACTURING SITE (LIFECORE BIOMEDICAL, LLC, CHASKA, MN) FOR RAW MATERIAL AND FINISHED PRODUCTS. |
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