Approval for the addition of 2. 5ml and 5. 0ml fill volumes to the existing 4. 0ml fill volume, using the same 5ml syringe and packaging.
| Device | ARTERX SURGICAL SEALANT 2.5ML AND 5.0 FILL VOLUMES |
| Classification Name | Sealant, Polymerizing |
| Generic Name | Sealant, Polymerizing |
| Applicant | Baxter Healthcare Corporation |
| Date Received | 2013-09-03 |
| Decision Date | 2013-11-25 |
| PMA | P100030 |
| Supplement | S001 |
| Product Code | NBE |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Baxter Healthcare Corporation one Baxter Parkway deerfield, IL 60015 |
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