PMA P150016

Device: TRIDYNE™ Vascular Sealant
Applicant: Neomend, Inc.
PMA number: P150016
Supplement: S022
Product code: NBE
Decision date: 2026-03-12
Generic name: Sealant, polymerizing
Approval order statement: For the reduction of testing frequency for Air Flow Test, Standard Spray Tips and Extended Spray Tips; removal of Neomend Inc. Pouch Peel Strength Testing for Incoming Packaging Materials with the adoption of Supplier-Performed ASTM F88 Testing for Chevron Seal Pouches; and elimination of SDS-PAGE Lot Release Testing

Current openFDA PMA Record#

Device: TRIDYNE™ Vascular Sealant
Applicant: Neomend, Inc.
PMA number: P150016
Supplement: S028
Product code: NBE
Generic name: Sealant, polymerizing
Decision date: 2026-03-12
Decision code: OK30
Date received: 2026-02-17
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: For the reduction of testing frequency for Air Flow Test, Standard Spray Tips and Extended Spray Tips; removal of Neomend Inc. Pouch Peel Strength Testing for Incoming Packaging Materials with the adoption of Supplier-Performed ASTM F88 Testing for Chevron Seal Pouches; and elimination of SDS-PAGE Lot Release Testing