|
Device | BVI 1% OVD (1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID) |
Generic Name | AID, SURGICAL, VISCOELASTIC |
Regulation Number | 886.4275 |
Applicant | Altacor Ltd. Merlin House, Brunel Road Theale RG7 4 |
PMA Number | P960011 |
Supplement Number | S025 |
Date Received | 04/28/2014 |
Decision Date | 05/27/2014 |
Product Code |
LZP |
Advisory Committee |
Ophthalmic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement USE OF A NEW INTERMEDIATE VESSEL FOR BVI 1% AND EUFLEXXA OVD. |