PMA P010047S059

Device: Progel Pleural Air Leak Sealant
Applicant: Neomend, Inc.
PMA number: P010047
Supplement: S059
Product code: NBE
Decision date: 2018-07-26
Classification: Sealant, Polymerizing
Generic name: Sealant, polymerizing
Approval order statement: Change to the radiation dose used for the sterile Nalgene plastic containers used to store and deliver the Polyethylene Glycol Disuccinimidyl Succinate (PEG(SS)2) raw material to Neomend.

Current openFDA PMA Record#

Device: Progel Pleural Air Leak Sealant
Applicant: Neomend, Inc.
PMA number: P010047
Supplement: S059
Product code: NBE
Generic name: Sealant, polymerizing
Decision date: 2018-07-26
Decision code: OK30
Date received: 2018-06-27
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change to the radiation dose used for the sterile Nalgene plastic containers used to store and deliver the Polyethylene Glycol Disuccinimidyl Succinate (PEG(SS)2) raw material to Neomend.