PMA P150016S007

Device: TRIDYNE VASCULAR SEALANT; TRIDYNE VS Standard Spray Tips; TRIDYNE VS 6 Extended Spray Tip
Applicant: Neomend, Inc.
PMA number: P150016
Supplement: S007
Product code: NBE
Decision date: 2017-12-20
Classification: Sealant, Polymerizing
Generic name: Sealant, polymerizing
Approval order statement: Changes to the processing of the Human Serum Albumin (HSA) and Polyethylene Glycol (PEG) components of the Tridyne Vascular Sealant.

Current openFDA PMA Record#

Device: TRIDYNE VASCULAR SEALANT; TRIDYNE VS Standard Spray Tips; TRIDYNE VS 6 Extended Spray Tip
Applicant: Neomend, Inc.
PMA number: P150016
Supplement: S007
Product code: NBE
Generic name: Sealant, polymerizing
Decision date: 2017-12-20
Decision code: OK30
Date received: 2017-11-28
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Changes to the processing of the Human Serum Albumin (HSA) and Polyethylene Glycol (PEG) components of the Tridyne Vascular Sealant.