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. |
|
Device | AMVISC/AMVISC PLUS SODIUM HYALURONATE |
Generic Name | AID, SURGICAL, VISCOELASTIC |
Regulation Number | 886.4275 |
Applicant | Bausch & Lomb, Inc. 50 Technology Drive Irvine, CA 92618 |
PMA Number | P810025 |
Supplement Number | S020 |
Date Received | 03/22/2002 |
Decision Date | 07/19/2002 |
Product Code |
LZP |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Express GMP Supplement |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR A NEW ASEPTIC MANUFACTURING SUITE LOCATED AT ANIKA THERAPEUTICS, INC., WOBURN, MASSACHUSETTS. |
|
|