This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Alternate supplier.
| Device | COSEAL SURGICAL SEALANT |
| Classification Name | Sealant, Polymerizing |
| Generic Name | Sealant, Polymerizing |
| Applicant | BAXTER BIO SCIENCE |
| Date Received | 2008-03-24 |
| Decision Date | 2008-04-23 |
| PMA | P030039 |
| Supplement | S009 |
| 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 | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BAXTER BIO SCIENCE 32650 N Wilson Rd mail Stop Wg2-3s round Lake, IL 60073 |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 35413765583415 | P030039 | 024 |