PMA P960011S018

Device: BVI 1% OVD-SODIUM HYALURONATE VISCOELASTIC
Applicant: Altacor , Ltd.
PMA number: P960011
Supplement: S018
Product code: LZP
Decision date: 2011-03-08
Classification: Aid, Surgical, Viscoelastic
Generic name: AID, SURGICAL, VISCOELASTIC
Approval order statement: APPROVAL FOR THE INCLUSION OF DIRECTIONS FOR PROPER FINGER FLANGE ORIENTATION IN THE INSTRUCTIONS FOR USE. IN ADDITIONAL APPROVAL TO CHANGE THE TRADE NAME OF THE DEVICE FROM BD 1% OVD SODIUM HYALURONATE TO BVI 1% OVD SODIUM HYALURONATE.

Current openFDA PMA Record#

Device: BVI 1% OVD-SODIUM HYALURONATE VISCOELASTIC
Applicant: Altacor , Ltd.
PMA number: P960011
Supplement: S018
Product code: LZP
Generic name: AID, SURGICAL, VISCOELASTIC
Decision date: 2011-03-08
Decision code: APPR
Date received: 2011-02-10
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR THE INCLUSION OF DIRECTIONS FOR PROPER FINGER FLANGE ORIENTATION IN THE INSTRUCTIONS FOR USE. IN ADDITIONAL APPROVAL TO CHANGE THE TRADE NAME OF THE DEVICE FROM BD 1% OVD SODIUM HYALURONATE TO BVI 1% OVD SODIUM HYALURONATE.