PMA P150016S015

Device: Tridyne Vascular Sealent
Applicant: Neomend, Inc.
PMA number: P150016
Supplement: S015
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: Tridyne Vascular Sealent
Applicant: Neomend, Inc.
PMA number: P150016
Supplement: S015
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.