PMA P150016S005

Device: TRIDYNE VASCULAR SEALANT
Applicant: Neomend, Inc.
PMA number: P150016
Supplement: S005
Product code: NBE
Decision date: 2017-07-06
Classification: Sealant, Polymerizing
Generic name: Sealant, polymerizing
Approval order statement: Approval to modify the storage conditions of Tridyne Vascular Sealant (Tridyne VS) from refrigerated conditions 2-8°C (36-46°F) to include a controlled ambient temperature storage excursion of 8-25°C (46-77°F) for a period of up to 35 days within the approved shelf life of 24 months.

Current openFDA PMA Record#

Device: TRIDYNE VASCULAR SEALANT
Applicant: Neomend, Inc.
PMA number: P150016
Supplement: S005
Product code: NBE
Generic name: Sealant, polymerizing
Decision date: 2017-07-06
Decision code: APPR
Date received: 2017-04-10
Supplement type: Real-Time Process
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval to modify the storage conditions of Tridyne Vascular Sealant (Tridyne VS) from refrigerated conditions 2-8°C (36-46°F) to include a controlled ambient temperature storage excursion of 8-25°C (46-77°F) for a period of up to 35 days within the approved shelf life of 24 months.