PMA P960011S028

Device
BVI 1%OVD (fonnerly BD 1%OVD and Biolon)
Applicant
Altacor , Ltd.
PMA number
P960011
Supplement
S028
Product code
LZP
Decision date
2018-01-04
Classification
Aid, Surgical, Viscoelastic
Generic name
AID, SURGICAL, VISCOELASTIC
Approval order statement
Alternative, additional supplier for syringe components, and a tamper-evident tip cap closure system for the BVI 1% OVD®.

Current openFDA PMA Record#

Device
BVI 1%OVD (fonnerly BD 1%OVD and Biolon)
Applicant
Altacor , Ltd.
PMA number
P960011
Supplement
S028
Product code
LZP
Generic name
AID, SURGICAL, VISCOELASTIC
Decision date
2018-01-04
Decision code
OK30
Date received
2017-12-07
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Alternative, additional supplier for syringe components, and a tamper-evident tip cap closure system for the BVI 1% OVD®.