PMA P150016S026

Device: TRIDYNE™ Vascular Sealant
Applicant: Neomend, Inc.
PMA number: P150016
Supplement: S026
Product code: NBE
Decision date: 2025-06-18
Classification: Cardiovascular
Generic name: Sealant, polymerizing
Approval order statement: For the reduction of TM-0080 Particulate Testing for PEG Filled Cartridges (78-8110-3501-9) and to qualify an alternate supplier (Neomend, Inc.) to perform Sodium Concentration Testing (TM-0056 REV.1).

Current openFDA PMA Record#

Device: TRIDYNE™ Vascular Sealant
Applicant: Neomend, Inc.
PMA number: P150016
Supplement: S026
Product code: NBE
Generic name: Sealant, polymerizing
Decision date: 2025-06-18
Decision code: OK30
Date received: 2025-05-30
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: For the reduction of TM-0080 Particulate Testing for PEG Filled Cartridges (78-8110-3501-9) and to qualify an alternate supplier (Neomend, Inc.) to perform Sodium Concentration Testing (TM-0056 REV.1).