|
Device | VISCOAT 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 | S015 |
Date Received | 08/14/1995 |
Decision Date | 03/22/1996 |
Product Code |
LZP |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR: 1)ALTERNATE MANUFACTURING SITE AT PUURS, BELGIUM; 2)USE OF 100% ETHYLENE OXIDE IN THE STERILIZATION PROCESS; AND 3)INCREASE IN THE ALLOWABLE FILL VOLUME TO 0.75 ML (THIS WAS INADVERTENTLY NOT INCLUDED IN OUR APPROVABLE LETTER OF 13-FEB-96) |