|
Device | VISCOAT/DUOVISC/DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE |
Generic Name | AID, SURGICAL, VISCOELASTIC |
Regulation Number | 886.4275 |
Applicant | ALCON LABORATORIES 6201 S FREEWAY FT WORTH, TX 76134 |
PMA Number | P840064 |
Supplement Number | S038 |
Date Received | 10/31/2008 |
Decision Date | 02/27/2009 |
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 | Yes |
Approval Order Statement APPROVAL FOR THE ADDITION OF A SECOND LINE-PERFORM LABELING AND ASSEMBLY OF OPHTHALMIC VISCOSURGICAL DEVICES (OVD). |