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 | S009 |
Date Received | 09/22/1995 |
Decision Date | 03/26/1996 |
Product Code |
LZP |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MANUFACTURE OF DUOVISC AT ALCON-COUVREUR, PUURS, BELGIUM AND A SINGLE BLISTER PACKAGE WHICH WILL CONTAIN BOTH PROVISC AND VISCOAT WITH THEIR DELIVERY CANNULAS (24 MONTHS EXPIRATION) |
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