PMA P150016S022

Device
TRIDYNE Vascular Sealant
Applicant
Neomend, Inc.
PMA number
P150016
Supplement
S022
Product code
NBE
Decision date
2022-09-07
Generic name
Sealant, polymerizing
Approval order statement
Relocation of the Glass Cartridge Syringe Manufacturing supplier site.

Current openFDA PMA Record#

Device
TRIDYNE Vascular Sealant
Applicant
Neomend, Inc.
PMA number
P150016
Supplement
S022
Product code
NBE
Generic name
Sealant, polymerizing
Decision date
2022-09-07
Decision code
OK30
Date received
2022-08-08
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Relocation of the Glass Cartridge Syringe Manufacturing supplier site.