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 (OPHTHALMIC VISCOSURGICAL DEVICES) |
Generic Name | AID, SURGICAL, VISCOELASTIC |
Regulation Number | 886.4275 |
Applicant | Bausch & Lomb, Inc. 50 Technology Drive Irvine, CA 92618 |
PMA Number | P810025 |
Supplement Number | S029 |
Date Received | 09/30/2010 |
Decision Date | 01/17/2012 |
Product Code |
LZP |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT ANIKA THERAPEUTICS, INC., IN BEDFORD, MASSACHUSETTS. |
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