|
Device | BVI 1% OVD-SODIUM HYALURONATE VISCOELASTIC |
Generic Name | AID, SURGICAL, VISCOELASTIC |
Regulation Number | 886.4275 |
Applicant | Altacor Ltd. Merlin House, Brunel Road Theale RG7 4 |
PMA Number | P960011 |
Supplement Number | S018 |
Date Received | 02/10/2011 |
Decision Date | 03/08/2011 |
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 INCLUSION OF DIRECTIONS FOR PROPER FINGER FLANGE ORIENTATION IN THE INSTRUCTIONS FOR USE. IN ADDITIONAL APPROVAL TO CHANGE THE TRADE NAME OF THE DEVICE FROM BD 1% OVD SODIUM HYALURONATE TO BVI 1% OVD SODIUM HYALURONATE. |