Approval of the following changes to the post-approval study for the device:1) change the definition of the minimum necessary follow-up from 60 to 45 days for the retrospective control subjects only; and 2) allow any new study sites that do not have 90 day standard of care visits to enroll prospective subjects only (duraseal and/or control). This would allow new sites to contribute subjects prospectively inside the study window (60 to 120 days), but exclude retrospective subjects that would potentially have been seen outside of the study window thus maintaining control over follow-up compliance.
| Device | DURASEAL EXACT SPINE SEALANT |
| Classification Name | Sealant, Dural |
| Generic Name | Sealant, Dural |
| Applicant | INTEGRA LIFESCIENCES CORPORATION |
| Date Received | 2015-02-02 |
| Decision Date | 2015-05-11 |
| PMA | P080013 |
| Supplement | S011 |
| Product Code | NQR |
| Advisory Committee | Neurology |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol - Osb |
| 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