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.
| Device | PreveLeak Surgical Sealant |
| Classification Name | Sealant, Polymerizing |
| Generic Name | Sealant, Polymerizing |
| Applicant | Baxter Healthcare Corporation |
| Date Received | 2017-07-03 |
| Decision Date | 2017-12-21 |
| Notice Date | 2018-01-09 |
| PMA | P100030 |
| Supplement | S008 |
| Product Code | NBE |
| Docket Number | 17M-6971 |
| Advisory Committee | Cardiovascular |
| Supplement Type | Panel Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Baxter Healthcare Corporation one Baxter Parkway deerfield, IL 60015 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P100030 | | Original Filing |
| S016 |
2021-11-10 |
30-day Notice |
| S015 |
2021-06-28 |
30-day Notice |
| S014 |
2020-09-14 |
Real-time Process |
| S013 | | |
| S012 | | |
| S011 |
2017-07-31 |
30-day Notice |
| S010 |
2017-07-26 |
30-day Notice |
| S009 |
2017-07-07 |
135 Review Track For 30-day Notice |
| S008 |
2017-07-03 |
Panel Track |
| S007 |
2017-05-30 |
Real-time Process |
| S006 | | |
| S005 |
2016-07-26 |
Normal 180 Day Track No User Fee |
| S004 |
2014-05-22 |
Normal 180 Day Track No User Fee |
| S003 | | |
| S002 |
2013-09-03 |
Real-time Process |
| S001 |
2013-09-03 |
Real-time Process |
NIH GUDID Devices