PMA P010047S048

Device: PROGEL Pleural Air Leak Sealant (PALS), PROGEL Spare Tips accessory, PROGEL 6 and 11 Extended Tips accessory
Applicant: Neomend, Inc.
PMA number: P010047
Supplement: S048
Product code: NBE
Decision date: 2017-10-12
Classification: Sealant, Polymerizing
Generic name: Sealant, polymerizing
Approval order statement: Changes to the manufacturing of the extended applicator tip, assembly/sealing/packaging, labeling processes, and environmental controls.

Current openFDA PMA Record#

Device: PROGEL Pleural Air Leak Sealant (PALS), PROGEL Spare Tips accessory, PROGEL 6 and 11 Extended Tips accessory
Applicant: Neomend, Inc.
PMA number: P010047
Supplement: S048
Product code: NBE
Generic name: Sealant, polymerizing
Decision date: 2017-10-12
Decision code: OK30
Date received: 2017-09-07
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Changes to the manufacturing of the extended applicator tip, assembly/sealing/packaging, labeling processes, and environmental controls.