PMA P100030S013

Device: Preveleak Surgical Sealant
Applicant: Baxter Healthcare Corporation
Product code: NBE
Decision date: 2021-01-26
Generic name: Sealant, polymerizing
Approval order statement: Approval for an alternate supplier of chitosan chloride and a modification to the preparation steps of the proteinaceous solution component of Preveleak Surgical Sealant.

Current openFDA PMA Record#

Device: Preveleak Surgical Sealant
Applicant: Baxter Healthcare Corporation
PMA number: P100030
Supplement: S013
Product code: NBE
Generic name: Sealant, polymerizing
Decision date: 2021-01-26
Decision code: APPR
Date received: 2018-12-21
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for an alternate supplier of chitosan chloride and a modification to the preparation steps of the proteinaceous solution component of Preveleak Surgical Sealant.