|
Device | DUOVISC VISCOELASTIC SYSTEM |
Generic Name | AID, SURGICAL, VISCOELASTIC |
Regulation Number | 886.4275 |
Applicant | ALCON LABORATORIES 6201 S FREEWAY FT WORTH, TX 76134 |
PMA Number | P840064 |
Supplement Number | S014 |
Date Received | 05/30/1995 |
Decision Date | 08/02/1995 |
Product Code |
LZP |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR A MODIFICATION TO THE DUOVISC PACKAGE INSERT TO ALLOW FOR THE USE OF BOTH DEVICES IN A SINGLE OPHTHALMIC PROCEDURE |