|
Device | VISCOAT(R) SODIUM HYALURONATE |
Generic Name | AID, SURGICAL, VISCOELASTIC |
Regulation Number | 886.4275 |
Applicant | ALCON LABORATORIES 6201 S FREEWAY FT WORTH, TX 76134 |
PMA Number | P840064 |
Supplement Number | S022 |
Date Received | 12/15/2000 |
Decision Date | 02/13/2001 |
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 | Yes |
Approval Order Statement APPROVAL FOR LABELING CHANGES THAT ADD TWO PRECAUTIONARY STATEMENTS TO THE VISCOAT SOLUTION AND DUOVISC SYSTEM LABELING INSERT. |