PMA P880031S010

Device: AMO VITRAX (SODIUM HYALURONATE)
Applicant: Abbott Medical Optics, Inc.
PMA number: P880031
Supplement: S010
Product code: LZP
Decision date: 1996-04-08
Classification: Aid, Surgical, Viscoelastic
Generic name: AID, SURGICAL, VISCOELASTIC
Approval order statement: USE OF "PHARMACEUTICAL GRADE" SODIUM HYALURONATE POWDER SUPPLIED BY AKZO NOBEL CORPORATION, DIOSYNTH BV, KLOOSTERSTRAAT 6, 5349 AB OSS, THE NETHERLANDS, AS AN ALTERNATE SUPPLY OF SODIUM HYALURONATE POWDER FOR USE IN THE MANUFACTURE OF AMO VITRAX SODIUM HYALURONATE

Current openFDA PMA Record#

Device: AMO VITRAX (SODIUM HYALURONATE)
Applicant: Abbott Medical Optics, Inc.
PMA number: P880031
Supplement: S010
Product code: LZP
Generic name: AID, SURGICAL, VISCOELASTIC
Decision date: 1996-04-08
Decision code: APPR
Date received: 1995-11-24
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: USE OF "PHARMACEUTICAL GRADE" SODIUM HYALURONATE POWDER SUPPLIED BY AKZO NOBEL CORPORATION, DIOSYNTH BV, KLOOSTERSTRAAT 6, 5349 AB OSS, THE NETHERLANDS, AS AN ALTERNATE SUPPLY OF SODIUM HYALURONATE POWDER FOR USE IN THE MANUFACTURE OF AMO VITRAX SODIUM HYALURONATE