PMA P150016S010

Device: Tridyne Vascular Sealant
Applicant: Neomend, Inc.
PMA number: P150016
Supplement: S010
Product code: NBE
Decision date: 2018-09-12
Classification: Sealant, Polymerizing
Generic name: Sealant, polymerizing
Approval order statement: Approval for alternate sterilization sites located at Bard Regional Sterilization, 1211 Mary Magnum Boulevard, Madison, Georgia and Bard Regional Sterilization, 8195 Industrial Boulevard, Covington, Georgia.

Current openFDA PMA Record#

Device: Tridyne Vascular Sealant
Applicant: Neomend, Inc.
PMA number: P150016
Supplement: S010
Product code: NBE
Generic name: Sealant, polymerizing
Decision date: 2018-09-12
Decision code: APPR
Date received: 2017-11-29
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for alternate sterilization sites located at Bard Regional Sterilization, 1211 Mary Magnum Boulevard, Madison, Georgia and Bard Regional Sterilization, 8195 Industrial Boulevard, Covington, Georgia.