Approval for the arterx surgical sealant. This device is indicated for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
| Device | ARTERX SURGICAL SEALANT |
| Classification Name | Sealant, Polymerizing |
| Generic Name | Sealant, Polymerizing |
| Applicant | Baxter Healthcare Corporation |
| Date Received | 2010-07-27 |
| Decision Date | 2013-03-01 |
| Notice Date | 2013-03-14 |
| PMA | P100030 |
| Supplement | S |
| Product Code | NBE |
| Docket Number | 13M-0281 |
| Advisory Committee | Cardiovascular |
| 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