Approval for labeling change to add a warning regarding use of the sealant to adhere objects to tissue.
| Device | COSEAL SURGICAL SEALANT |
| Classification Name | Sealant, Polymerizing |
| Generic Name | Sealant, Polymerizing |
| Applicant | BAXTER BIO SCIENCE |
| Date Received | 2006-02-02 |
| Decision Date | 2006-03-10 |
| PMA | P030039 |
| Supplement | S003 |
| Product Code | NBE |
| Docket Number | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia |
| Advisory Committee | Cardiovascular |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BAXTER BIO SCIENCE 32650 N Wilson Rd mail Stop Wg2-3s round Lake, IL 60073 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P030039 | | Original Filing |
| S027 |
2021-09-28 |
30-day Notice |
| S026 |
2021-04-21 |
Normal 180 Day Track |
| S025 |
2020-04-17 |
Real-time Process |
| S024 | | |
| S023 |
2018-05-03 |
Real-time Process |
| S022 |
2018-02-20 |
30-day Notice |
| S021 |
2018-01-25 |
Special (immediate Track) |
| S020 |
2017-12-04 |
Normal 180 Day Track No User Fee |
| S019 |
2015-10-16 |
30-day Notice |
| S018 | | |
| S017 | | |
| S016 |
2010-06-01 |
Special (immediate Track) |
| S015 |
2010-03-02 |
Special (immediate Track) |
| S014 |
2009-09-04 |
Real-time Process |
| S013 |
2009-03-17 |
135 Review Track For 30-day Notice |
| S012 |
2008-11-07 |
30-day Notice |
| S011 |
2008-08-29 |
Special (immediate Track) |
| S010 |
2008-07-01 |
Real-time Process |
| S009 |
2008-03-24 |
30-day Notice |
| S008 |
2007-11-15 |
30-day Notice |
| S007 |
2007-10-31 |
30-day Notice |
| S006 | | |
| S005 |
2007-06-25 |
30-day Notice |
| S004 |
2006-04-05 |
Normal 180 Day Track |
| S003 |
2006-02-02 |
Special (immediate Track) |
| S002 |
2006-01-17 |
Normal 180 Day Track No User Fee |
| S001 |
2003-12-18 |
Normal 180 Day Track No User Fee |
NIH GUDID Devices