|
Device | BD 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 | S017 |
Date Received | 12/18/2009 |
Decision Date | 06/15/2010 |
Product Code |
LZP |
Advisory Committee |
Ophthalmic |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE IN MANUFACTURE USING NEW EQUIPMENT. |