|
Device | COEASE SODIUM HYALURONATE |
Generic Name | AID, SURGICAL, VISCOELASTIC |
Regulation Number | 886.4275 |
Applicant | Anika Therapeutics, Inc. 32 WIGGINS AVENUE BEDFORD, MA 01730 |
PMA Number | P000046 |
Supplement Number | S003 |
Date Received | 04/17/2002 |
Decision Date | 05/08/2002 |
Product Code |
LZP |
Advisory Committee |
Ophthalmic |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A PRIVATE DISTRIBUTOR AGREEMENT WITH ADVANCED MEDICAL OPTICS. THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME COEASE SODIUM HYALURONATE AND WILL BE DISTRIBUTED IN VOLUMES OF 0.5 ML AND 0.8 ML. |