|
Device | VISCOAT(R) VISCOELASTIC SOLUTION |
Generic Name | AID, SURGICAL, VISCOELASTIC |
Regulation Number | 886.4275 |
Applicant | ALCON LABORATORIES 6201 S FREEWAY FT WORTH, TX 76134 |
PMA Number | P840064 |
Supplement Number | S021 |
Date Received | 03/23/1998 |
Decision Date | 06/29/1998 |
Product Code |
LZP |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for the addition of a cannula locking ring to the currentl-marketed delivery system for VISCOAT(R). |