PMA P010047S069

Device: PROGEL™ Pleural Air Leak Sealant
Applicant: Neomend, Inc.
PMA number: P010047
Supplement: S069
Product code: NBE
Decision date: 2024-03-05
Classification: Anesthesiology
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: PROGEL™ Pleural Air Leak Sealant
Applicant: Neomend, Inc.
PMA number: P010047
Supplement: S069
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