|
Device | PreveLeak Surgical Sealant |
Generic Name | Sealant, polymerizing |
Applicant | Baxter Healthcare Corporation One Baxter Parkway Deerfield, IL 60015 |
PMA Number | P100030 |
Supplement Number | S008 |
Date Received | 07/03/2017 |
Decision Date | 12/21/2017 |
Product Code |
NBE |
Docket Number | 17M-6971 |
Notice Date | 01/09/2018 |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT01957904
|
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for Preveleak Surgical Sealant. The device is indicated for use in vascular and cardiac reconstructions (excluding application to arterial and venous grafts used in coronary artery bypass graft surgery) to achieve adjunctive hemostasis by mechanically sealing areas of potential leakage. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|