PMA P150016S024

Device: TRIDYNE™ Vascular Sealant
Applicant: Neomend, Inc.
PMA number: P150016
Supplement: S024
Product code: NBE
Decision date: 2024-03-05
Classification: Cardiovascular
Generic name: Sealant, polymerizing
Approval order statement: to change the incoming component embedded particulate specification for the Chemistry Kit Lids and Trays for the PROGEL Pleural Air Leak Sealant and the TRIDYNE Vascular Sealant devices

Current openFDA PMA Record#

Device: TRIDYNE™ Vascular Sealant
Applicant: Neomend, Inc.
PMA number: P150016
Supplement: S024
Product code: NBE
Generic name: Sealant, polymerizing
Decision date: 2024-03-05
Decision code: OK30
Date received: 2024-01-31
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: to change the incoming component embedded particulate specification for the Chemistry Kit Lids and Trays for the PROGEL Pleural Air Leak Sealant and the TRIDYNE Vascular Sealant devices