FDA.reportPublic FDA data

PMA P960011S029

Device
BVI 1% OVD (formerly BD 1% OVD and Biolon)
Applicant
Altacor , Ltd.
PMA number
P960011
Supplement
S029
Product code
LZP
Decision date
2018-03-15
Classification
Aid, Surgical, Viscoelastic
Generic name
AID, SURGICAL, VISCOELASTIC
Approval order statement
Approval for revisions to the labeling trade name from BVI 1% OVD® (1% sodium hyaluronate viscoelastic surgical aid fluid) to BIOLON, distributor, and Instructions for Use for the inclusion of a tamper-evident tip cap closure system.

Current openFDA PMA Record#

Device
BVI 1% OVD (formerly BD 1% OVD and Biolon)
Applicant
Altacor , Ltd.
PMA number
P960011
Supplement
S029
Product code
LZP
Generic name
AID, SURGICAL, VISCOELASTIC
Decision date
2018-03-15
Decision code
APPR
Date received
2018-02-12
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for revisions to the labeling trade name from BVI 1% OVD® (1% sodium hyaluronate viscoelastic surgical aid fluid) to BIOLON, distributor, and Instructions for Use for the inclusion of a tamper-evident tip cap closure system.