|
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 | S027 |
Date Received | 12/06/2017 |
Decision Date | 01/02/2018 |
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 Increasing the formulation capacity for the manufacturing of BVI 1% OVD®. |