Approval for manufacturing sites located at avail/med s. A. De c. V. , c. Industrial lt. 001 mz 105, no. 206905 int. A. Col. Cd. Industrial, tijuana, baja california, mexico 22444 for manufacture of the duraseal® dural sealant system and duraseal® exact spine sealant system, and synergy health ast, llc, 9020 activity road, suite d, san diego, california for sterilization of the devices.
| Device | DuraSeal Exact Spine Sealant System |
| Classification Name | Sealant, Dural |
| Generic Name | Sealant, Dural |
| Applicant | INTEGRA LIFESCIENCES CORPORATION |
| Date Received | 2017-11-30 |
| Decision Date | 2018-03-21 |
| PMA | P080013 |
| Supplement | S015 |
| Product Code | NQR |
| Advisory Committee | Neurology |
| 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 | INTEGRA LIFESCIENCES CORPORATION 311 Enterprise Dr. plainsboro, NJ 08536 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P080013 | | Original Filing |
| S024 |
2022-09-07 |
30-day Notice |
| S023 |
2021-10-18 |
30-day Notice |
| S022 | | |
| S021 |
2020-08-17 |
30-day Notice |
| S020 |
2020-06-23 |
Special (immediate Track) |
| S019 | | |
| S018 |
2019-12-30 |
Normal 180 Day Track No User Fee |
| S017 |
2019-06-11 |
30-day Notice |
| S016 |
2018-10-29 |
30-day Notice |
| S015 |
2017-11-30 |
Normal 180 Day Track No User Fee |
| S014 |
2017-07-28 |
Normal 180 Day Track No User Fee |
| S013 |
2016-04-18 |
Real-time Process |
| S012 | | |
| S011 |
2015-02-02 |
Normal 180 Day Track No User Fee |
| S010 | | |
| S009 |
2013-06-04 |
135 Review Track For 30-day Notice |
| S008 |
2013-03-25 |
Normal 180 Day Track No User Fee |
| S007 |
2011-07-20 |
Special (immediate Track) |
| S006 |
2011-03-21 |
Normal 180 Day Track No User Fee |
| S005 | | |
| S004 |
2011-03-02 |
Normal 180 Day Track No User Fee |
| S003 |
2010-01-20 |
Normal 180 Day Track |
| S002 |
2009-10-14 |
Real-time Process |
| S001 |
2009-10-06 |
Normal 180 Day Track No User Fee |
NIH GUDID Devices