Approval of the propel contour sinus implant. This device is indicated for use in patients greater than or equal to 18 years of age to maintain patency of the frontal and maxillary sinus ostia following sinus surgery and locally deliver steroids to the sinus mucosa. The propel contour sinus implant separates/dilates mucosal tissues, prevents obstruction by adhesions/scarring, and reduces edema. The implant reduces the need for post-operative intervention such as surgical adhesion lysis and/or use of oral steroids.
| Device | PROPEL CONTOUR SINUS IMPLANT |
| Classification Name | Drug-eluting Sinus Stent |
| Generic Name | Drug-eluting Sinus Stent |
| Applicant | INTERSECT ENT |
| Date Received | 2016-08-01 |
| Decision Date | 2017-02-23 |
| Notice Date | 2017-03-10 |
| PMA | P100044 |
| Supplement | S023 |
| Product Code | OWO |
| Docket Number | 17M-1228 |
| Advisory Committee | Ear Nose & Throat |
| Supplement Type | Panel Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | INTERSECT ENT 1555 Adams Dr menlo Park, CA 94025 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P100044 | | Original Filing |
| S051 |
2022-11-25 |
30-day Notice |
| S050 |
2022-10-05 |
Special (immediate Track) |
| S049 |
2022-03-28 |
Real-time Process |
| S048 |
2021-01-11 |
Real-time Process |
| S047 | | |
| S046 |
2020-04-02 |
Real-time Process |
| S045 |
2020-03-26 |
Special (immediate Track) |
| S044 |
2019-09-10 |
30-day Notice |
| S043 | | |
| S042 |
2019-05-31 |
30-day Notice |
| S041 |
2019-05-03 |
30-day Notice |
| S040 |
2019-05-01 |
30-day Notice |
| S039 |
2019-04-26 |
30-day Notice |
| S038 | | |
| S037 |
2018-11-30 |
Real-time Process |
| S036 |
2018-10-12 |
Real-time Process |
| S035 |
2018-08-24 |
30-day Notice |
| S034 |
2018-08-08 |
30-day Notice |
| S033 |
2018-06-08 |
30-day Notice |
| S032 |
2018-05-02 |
30-day Notice |
| S031 |
2017-09-08 |
Special (immediate Track) |
| S030 |
2017-08-29 |
30-day Notice |
| S029 |
2017-05-30 |
30-day Notice |
| S028 |
2017-04-27 |
30-day Notice |
| S027 |
2017-03-01 |
Real-time Process |
| S026 |
2016-12-27 |
30-day Notice |
| S025 |
2016-09-30 |
30-day Notice |
| S024 |
2016-09-28 |
30-day Notice |
| S023 |
2016-08-01 |
Panel Track |
| S022 |
2016-06-16 |
135 Review Track For 30-day Notice |
| S021 |
2016-05-18 |
30-day Notice |
| S020 |
2016-03-25 |
Normal 180 Day Track No User Fee |
| S019 |
2015-09-30 |
30-day Notice |
| S018 |
2015-09-25 |
Panel Track |
| S017 |
2015-04-02 |
Normal 180 Day Track No User Fee |
| S016 |
2014-04-23 |
30-day Notice |
| S015 |
2014-01-16 |
30-day Notice |
| S014 |
2013-11-12 |
30-day Notice |
| S013 |
2013-11-04 |
Real-time Process |
| S012 |
2013-09-30 |
Normal 180 Day Track No User Fee |
| S011 |
2013-08-21 |
30-day Notice |
| S010 |
2013-06-25 |
Special (immediate Track) |
| S009 | | |
| S008 |
2013-03-04 |
Normal 180 Day Track No User Fee |
| S007 |
2013-01-29 |
30-day Notice |
| S006 |
2012-12-26 |
Normal 180 Day Track No User Fee |
| S005 |
2012-12-20 |
30-day Notice |
| S004 |
2012-12-14 |
Normal 180 Day Track No User Fee |
| S003 |
2012-10-01 |
Real-time Process |
| S002 |
2012-07-31 |
30-day Notice |
| S001 |
2012-03-12 |
Normal 180 Day Track |
NIH GUDID Devices