FDA.reportPublic FDA data

PMA P150016S018

Device
Tridyne Vascular Sealant
Applicant
Neomend, Inc.
PMA number
P150016
Supplement
S018
Product code
NBE
Decision date
2020-12-21
Generic name
Sealant, polymerizing
Approval order statement
Approval for changes to the HPLC chromatography column and test method used to evaluate the protein aggregate content in the Human Serum Albumin component of the chemistry kits contained in the PROGEL PALS and TRIDYNE VS finished devices.

Current openFDA PMA Record#

Device
Tridyne Vascular Sealant
Applicant
Neomend, Inc.
PMA number
P150016
Supplement
S018
Product code
NBE
Generic name
Sealant, polymerizing
Decision date
2020-12-21
Decision code
APPR
Date received
2020-05-01
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for changes to the HPLC chromatography column and test method used to evaluate the protein aggregate content in the Human Serum Albumin component of the chemistry kits contained in the PROGEL PALS and TRIDYNE VS finished devices.