|
Device | STAARVISC II 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 | S012 |
Date Received | 09/07/2005 |
Decision Date | 09/26/2005 |
Product Code |
LZP |
Advisory Committee |
Ophthalmic |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE CHANGE IN LABELING TO INCLUDE CANNULA ASSEMBLY INSTRUCTIONS. |