Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | DUOVISC VISCOELASTIC SYSTEM |
Generic Name | AID, SURGICAL, VISCOELASTIC |
Regulation Number | 886.4275 |
Applicant | Alcon Research, Ltd. 6201 SOUTH FREEWAY, R3-48 FORT WORTH, TX 76134-2099 |
PMA Number | P890047 |
Supplement Number | S007 |
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 | No |
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 |
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