PMA N17511S011

Device: HYSKON (32% DEXTRAN 70)
Applicant: Coopervision Surgical
PMA number: N17511
Supplement: S011
Product code: LTA
Decision date: 1995-07-18
Generic name: FLUID, HYSTEROSCOPY
Approval order statement: APPROVAL FOR THE USE OF A LAGARDE STERILIZER, 551015, IN YOUR CLAYTON, N.C. FACILITY TO TERMINALLY STERILIZE HYSKON HYSTEROSCOPY FLUID, 32% (DEXTRAN 70) IN 100 ML TO 250 ML GLASS BOTTLE:TRANSFER OF OWNERSHIP TO MADISAN PHARMACEUTICALS, INC.

Current openFDA PMA Record#

Device: HYSKON (32% DEXTRAN 70)
Applicant: Coopervision Surgical
PMA number: N17511
Supplement: S011
Product code: LTA
Generic name: FLUID, HYSTEROSCOPY
Decision date: 1995-07-18
Decision code: APPR
Date received: 1994-11-10
Supplement type: Normal 180 Day Track
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR THE USE OF A LAGARDE STERILIZER, 551015, IN YOUR CLAYTON, N.C. FACILITY TO TERMINALLY STERILIZE HYSKON HYSTEROSCOPY FLUID, 32% (DEXTRAN 70) IN 100 ML TO 250 ML GLASS BOTTLE:TRANSFER OF OWNERSHIP TO MADISAN PHARMACEUTICALS, INC.