Approval for manufacturing sites located at synergy health ast, llc, 9020 activity road suite d, san diego, california 92126 and synergy health ast, llc, 3200 lakeville highway, suite 120, petaluma, california 94954, for sterilization of the preveleak syringes and applicator tips.
| Device | PreveLeak Surgical Sealant & 10pk applictor tips |
| Classification Name | Sealant, Polymerizing |
| Generic Name | Sealant, Polymerizing |
| Applicant | Baxter Healthcare Corporation |
| Date Received | 2016-07-26 |
| Decision Date | 2017-05-19 |
| PMA | P100030 |
| Supplement | S005 |
| Product Code | NBE |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| 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