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 | VISCOAT 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 | S019 |
Date Received | 12/04/1996 |
Decision Date | 03/17/1998 |
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 | Yes |
Approval Order Statement APPROVAL FOR THE INCORPORATION OF VISCOAT AND PROVISC, WHICH MAKE UP THE DUOVISC PRODUCT, INTO A SINGLE PLASTIC TRAY, TO BE STERILIZED AND PROCESSED AT ALCON'S PUERTO RICO FACILITY; AND A CHANGE IN THE STERILIZATION PROCESS AT ALCON'S PUERTO RICO FACILITY FOR THE DUOVISC SYSTEM. |
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