|
Device | Amvisc and Amvisc Plus Ophthalmic Viscosurgical 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 | S037 |
Date Received | 08/23/2016 |
Decision Date | 06/28/2017 |
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 |
Approval Order Statement Approved GMP |