PMA P000046S023

Device: NUVISC
Applicant: Anika Therapeutics, Inc.
PMA number: P000046
Supplement: S023
Product code: LZP
Decision date: 2014-04-10
Classification: Aid, Surgical, Viscoelastic
Generic name: AID, SURGICAL, VISCOELASTIC
Approval order statement: APPROVAL FOR A NEW TRADE NAME. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME NUVISCTM AND IS INDICATED FOR USE DURING SURGERY IN THE ANTERIOR AND POSTERIOR SEGMENTS OF THE HUMAN EYE. PROCEDURES INCLUDE: CATARACT EXTRACTION, INTRAOCULAR LENS (IOL) IMPLANTATION, CORNEAL TRANSPLANTATION SURGERY, GLAUCOMA FILTERING SURGERY, AND SURGICAL PROCEDURES TO REATTACH THE RETINA.

Current openFDA PMA Record#

Device: NUVISC
Applicant: Anika Therapeutics, Inc.
PMA number: P000046
Supplement: S023
Product code: LZP
Generic name: AID, SURGICAL, VISCOELASTIC
Decision date: 2014-04-10
Decision code: APPR
Date received: 2014-01-15
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR A NEW TRADE NAME. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME NUVISCTM AND IS INDICATED FOR USE DURING SURGERY IN THE ANTERIOR AND POSTERIOR SEGMENTS OF THE HUMAN EYE. PROCEDURES INCLUDE: CATARACT EXTRACTION, INTRAOCULAR LENS (IOL) IMPLANTATION, CORNEAL TRANSPLANTATION SURGERY, GLAUCOMA FILTERING SURGERY, AND SURGICAL PROCEDURES TO REATTACH THE RETINA.