PMA P130023S005

Device: COHERA MEDICAL TISSUGLU SURGICAL ADHESIVE
Applicant: Cohera Medical, Inc.
PMA number: P130023
Supplement: S005
Product code: PJK
Decision date: 2017-07-27
Generic name: Tissue adhesive for internal use
Approval order statement: Approval for a modification to the TissuGlu® synthesis process where a small percentage of the stability reagents (sulfuric acid and DMSO stock solution) that are normally added at the end of the product synthesis process is instead added at the beginning of synthesis ("borrowed acid process").

Current openFDA PMA Record#

Device: COHERA MEDICAL TISSUGLU SURGICAL ADHESIVE
Applicant: Cohera Medical, Inc.
PMA number: P130023
Supplement: S005
Product code: PJK
Generic name: Tissue adhesive for internal use
Decision date: 2017-07-27
Decision code: APPR
Date received: 2017-01-26
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a modification to the TissuGlu® synthesis process where a small percentage of the stability reagents (sulfuric acid and DMSO stock solution) that are normally added at the end of the product synthesis process is instead added at the beginning of synthesis ("borrowed acid process").