|
Device | BIOLON 1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY |
Generic Name | AID, SURGICAL, VISCOELASTIC |
Regulation Number | 886.4275 |
Applicant | Altacor Ltd. Merlin House, Brunel Road Theale RG7 4 |
PMA Number | P960011 |
Supplement Number | S010 |
Date Received | 05/11/2005 |
Decision Date | 09/15/2005 |
Product Code |
LZP |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL TO INCLUDE IOLTECH, CIDRA, PUERTO RICO AS A DISTRIBUTOR FOR BIOLON IN THE UNITED STATES. |