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 AND AMVISC PLUS OPHTHALMIC VISCOSURICAL DEVICE (OVD) |
Generic Name | AID, SURGICAL, VISCOELASTIC |
Regulation Number | 886.4275 |
Applicant | Bausch & Lomb, Inc. 50 Technology Drive Irvine, CA 92618 |
PMA Number | P810025 |
Supplement Number | S033 |
Date Received | 03/21/2013 |
Decision Date | 04/24/2013 |
Product Code |
LZP |
Advisory Committee |
Ophthalmic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement ADD AN ALTERNATE SITE FOR ITS WORKING CELL BANK MANUFACTURER, ADD AN ALTERNATE VITAMIN SUPPLIER AND CHANGE SOURCED CHEMICALS TO USP GRADE. |
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