|
Device | Preveleak Surgical Sealant |
Generic Name | Sealant, polymerizing |
Applicant | Baxter Healthcare Corporation One Baxter Parkway Deerfield, IL 60015 |
PMA Number | P100030 |
Supplement Number | S013 |
Date Received | 12/21/2018 |
Decision Date | 01/26/2021 |
Product Code |
NBE |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
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. |